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51 result(s) found

Abdominal Aortic Aneurysm


Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.

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Aortic Aneurysm


Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.

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Atrial Fibrillation


AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

Sometimes, following open heart surgery, patients can develop irregular heart rhythms like atrial fibrillation. Atrial Fibrillation can occur in 30-50% of patients following open heart surgery. This is called, postoperative atrial fibrillation (POAF). POAF and related stroke/TIAs impact dying, and quality of life (QoL) for patients undergoing structural heart disease procedures. Usually these heart rhythms straighten out within your hospital stay but are typically treated with some drugs to decrease the ability of you blood to clot. Some people that have a high risk of bleeding cannot take blood thinners. This study is collecting information on the treatment of those subjects that develop POAF. This research study is also comparing how LAA closure impacts the physical health and quality of life (QoL) versus not having it closed in a special group of people, The left atrial appendage (LAA) is a small sac located on the upper chamber of your heart. This sac is thought to be the site where blood clots form and is believed to be associated with a significant risk of stroke/TIA in patients with specific risk factors like age, hypertension, atrial fibrillation, and diabetes. 

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Junctional AV Ablation in CRT-D Patients with Atrial Fibrillation

The primary aim of the study is to determine if patients with permanent AF who meet conventional criteria for CRT and undergo AVJ ablation have reduced ventricular remodeling (i.e. echocardardiographic improvement of LV end systolic volume), a potent marker of subsequent clinical deterioration, compared to patients who do not undergo AVJ ablation. This study is designed to test feasibility of enrollment and short-term improvement in surrogate endpoints, with anticipation of a full-scale large randomized clinical trial using hard outcome events if this phase is promising. 

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Cardiac Arrest


Acute Hemodynamics in Patients on AMCS

This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock. 

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Cardiac Arrhythmia


Junctional AV Ablation in CRT-D Patients with Atrial Fibrillation

The primary aim of the study is to determine if patients with permanent AF who meet conventional criteria for CRT and undergo AVJ ablation have reduced ventricular remodeling (i.e. echocardardiographic improvement of LV end systolic volume), a potent marker of subsequent clinical deterioration, compared to patients who do not undergo AVJ ablation. This study is designed to test feasibility of enrollment and short-term improvement in surrogate endpoints, with anticipation of a full-scale large randomized clinical trial using hard outcome events if this phase is promising. 

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Cardiac Failure


Epidermal Metabolomic Changes in Patients with Cardiogenic Shock

The purpose of this study is to determine the relationship between levels of metabolites, such as lactate in the sweat of the skinm, and the severity of heart failure.  We hope to determine whether the levels of lactate and other metabolites on the skin change as heart failure severity improves during a hospitalization.  This information oculd also be used to develop ways to detect worsening heart failure severity using a sweat-based test.  The study seeks to recruit patients admitted to Tufts Medical Center due to decompensated heart failure.   There are 2 study visits which each require the collection of 15ml of fasted venous blood, a completed KCCQ, and holding a damped gauze between the palms for 2 minutes.   The baseline study visit takes place within 72 hour of admission and the second study visit takes place within 3 and 60 days of the baseline visit when the patient meets criteria for clinical stability.

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How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pump). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation. 

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A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

More

Acute Hemodynamics in Patients on AMCS

This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock. 

More

Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is being done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failure and are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

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How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pump). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

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Non-Invasive Measurement of Capillary Oxygenation during Exercise in Ambulatory Advanced Heart Failure Patients

At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.

More

Transcatheter Aortic Valve Replacement to Unload the Left ventricle in patients with Advanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

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Cardiomyopathy


Prevalence of Transthyretin Cardiac Amyloidosis (ATTR-CM) Among Patients with Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy (HCM) is a genetic disease where the heart muscles become thicker because of the disease.   We use electrocardiogram, echocardiogram or cardiac magnetic resonance imaging (CMR) tests to see if someone might have HCM.  Another disease, transthyretin cardiac amyloidosis (ATTR-CM) can also cause the heart to become thick and look similar to HCM on these tests (usually in patients who are over 60 years old).

Recent research suggests that up to 10% of patients ≥ 60 years of age who have been diagnosed with HCM, may actually have ATTR-CM.  However, no formal research study has been done to confirm if this is what is happening.   Standard practice at Tufts is that patients ≥ 60 years of age have routine testing for HCM (including electrocardiogram, echocardiogram, and CMR) and a special test (called a pryophosphate scan) specifically to evaluate for ATTR-CM.  This is important as ATTR-CM is treated differently than HCM.

The research team is inviting participants to be included in a registry in order to look at the difference between the two diseases and how they are diagnosed.  This study's registry is a compilation of various cardiac images, lab tests, and medical histories of patients with HCM and ATTR-CM. If they choose to participate, they will be included in a  registry using the following information: clinical history, lab tests, echocardiogram, cardiac magnetic resonance imaging (CMR), and pyrophosphate scan.   We will look at this information to understand how often patients originally diagnosed with HCM were later diagnosed with ATTR-CM instead.

 

 

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A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

More

Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is being done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failure and are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

More

How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pump). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

More

Non-Invasive Measurement of Capillary Oxygenation during Exercise in Ambulatory Advanced Heart Failure Patients

At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.

More

Cardiovascular Disease


HeartMate PHP™ Coronary Interventions in High-Risk Patients Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.

Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.

Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.

Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,

hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.  Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.

Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.

Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.

All patients will have a follow-up visit at 90 days post-device removal.

More

How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pump). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation. 

More

A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

More

Cardiovascular Tissue and DNA Banking Study

Collecting and storing heart tissue and blood samples from consented Tufts Medical Center patients for the purpose of cardiovascular research.

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Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is being done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failure and are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

More

How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pump). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

More

Transcatheter Aortic Valve Replacement to Unload the Left ventricle in patients with Advanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

More

Coronary Artery Disease


HeartMate PHP™ Coronary Interventions in High-Risk Patients Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.

Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.

Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.

Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,

hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.  Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.

Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.

Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.

All patients will have a follow-up visit at 90 days post-device removal.

More

Covid-19


Prevention of COVID-19 Progression Through Early Administration of Inhaled Nitric Oxide

The purpose of this study is to investigate the potential for inhaled NO to reduce clinical worsening of hospitalized, high-risk patients with early COVID-19 to progressive systemic de-oxygenation, intubation, and death. This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in hospitalized patients with COVID-19 at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age  60 years, type II DM, hypertension, and obesity.

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Healthy Volunteers


Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.

More

Heart Diseases


HeartMate PHP™ Coronary Interventions in High-Risk Patients Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.

Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.

Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.

Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,

hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.  Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.

Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.

Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.

All patients will have a follow-up visit at 90 days post-device removal.

More

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).

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Global cVAD Registry

The Global cVAD Registry collects data retrospectively from hospital medical records for patients, who received one or multiple Impella devices during routine care. This registry is an observational, multicenter, retrospective records review. The purpose of this registry is to capture data that reflects 'real world' use of Impella devices in clinical practice and provide insight into patient characteristics, overall health, patterns of care, quality of care and performance during the hospital stay. 

More

Transcatheter Aortic Valve Replacement to Unload the Left ventricle in patients with Advanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

More

Heart Failure


Epidermal Metabolomic Changes in Patients with Cardiogenic Shock

The purpose of this study is to determine the relationship between levels of metabolites, such as lactate in the sweat of the skinm, and the severity of heart failure.  We hope to determine whether the levels of lactate and other metabolites on the skin change as heart failure severity improves during a hospitalization.  This information oculd also be used to develop ways to detect worsening heart failure severity using a sweat-based test.  The study seeks to recruit patients admitted to Tufts Medical Center due to decompensated heart failure.   There are 2 study visits which each require the collection of 15ml of fasted venous blood, a completed KCCQ, and holding a damped gauze between the palms for 2 minutes.   The baseline study visit takes place within 72 hour of admission and the second study visit takes place within 3 and 60 days of the baseline visit when the patient meets criteria for clinical stability.

More

How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pump). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation. 

More

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 over 12 Weeks in Patients with Heart Failure with Preserved Ejection Fraction (CAPACITY HFpEF)

This study will evaluate the safety and efficacy of 3 doses of IW-1973 compared with placebo, a drug that looks like the study drug but has none of the active ingredients. During the study participants will be asked to take the drug daily for about 12 weeks, 2 weeks of taking the drug twice-daily followed by 10 weeks of taking the drug once-daily. At the Day 1 Visit, patients will spend about 2 hours going through study required assessments to help determine if they qualify for the study. Once those assessments are finished patients will be randomized, randomly assigned to one of the groups: 10mg study drug, 20mg study drug, 40mg study drug, or placebo daily. After Visit 1 participants will be asked to return to the clinical at Week 4, Week 8, and End of Treatment for study drug administration; safety efficacy, and a few additional assessments; and to receive additional study drug and other supplies, as applicable. Patients will return to the clinic 28 days (day 113+/-7) after their last study drug dose for the final Follow-up Visit. 

More

A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

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A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).

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Accuracy of echocardiographic estimation of atrial pressure: A prospective, observational study

The purpose of this study is to determine how accurate transthoracic echocardiogram (echo) is at estimating the pressures within your heart, as compared to the most accurate test of right heart catheterization (RHC, also called "Swan" catheter). Echo is a test that uses ultrasound to get pictures of your heart through an ultrasound probe that is placed on your chest or upper abdomen. RHC is a procedure where a catheter is inserted into your heart through a large vein (in your neck or groin), and the pressures within your heart are measured directly. This study will show us if echo measurements can be used reliability in patients in the future without having to do invasive catheterization. Patients undergoing both echo and RHC, as determined by their doctor, while in the hospital as part of standard medical care will be enrolled in this study. There is no additional testing that will be done as part of this study. 

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Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is being done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failure and are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

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How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pump). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

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Non-Invasive Measurement of Capillary Oxygenation during Exercise in Ambulatory Advanced Heart Failure Patients

At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.

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Renal Hemodynamics in Patients on AMCS

This study explores changes in blood flow in the kidney before and after activation of Impella or ECMO devices, used to support subjects in cardiogenic shock. 

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Transcatheter Aortic Valve Replacement to Unload the Left ventricle in patients with Advanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

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Hematologic Disorders


Renal Hemodynamics in Patients on AMCS

This study explores changes in blood flow in the kidney before and after activation of Impella or ECMO devices, used to support subjects in cardiogenic shock. 

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Hypertrophic Cardiomyopathy


Exercise in Genetic Cardiovascular Conditions (Lifestyle and Exercise in Hypertrophic Cardiomyopathy "LIVE-HCM"/Lifestyle and Exercise in the Long QT Syndrome "LIVE-LQTS")

The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM and long QT syndrome (LQTS)

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Long QT Syndrome


Exercise in Genetic Cardiovascular Conditions (Lifestyle and Exercise in Hypertrophic Cardiomyopathy "LIVE-HCM"/Lifestyle and Exercise in the Long QT Syndrome "LIVE-LQTS")

The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM and long QT syndrome (LQTS)

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Myocardial Heart Disease


Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator

The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy.

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Pulmonary Hypertension


A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).

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Transthyretin Cardiac Amyloidosis


Prevalence of Transthyretin Cardiac Amyloidosis (ATTR-CM) Among Patients with Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy (HCM) is a genetic disease where the heart muscles become thicker because of the disease.   We use electrocardiogram, echocardiogram or cardiac magnetic resonance imaging (CMR) tests to see if someone might have HCM.  Another disease, transthyretin cardiac amyloidosis (ATTR-CM) can also cause the heart to become thick and look similar to HCM on these tests (usually in patients who are over 60 years old).

Recent research suggests that up to 10% of patients ≥ 60 years of age who have been diagnosed with HCM, may actually have ATTR-CM.  However, no formal research study has been done to confirm if this is what is happening.   Standard practice at Tufts is that patients ≥ 60 years of age have routine testing for HCM (including electrocardiogram, echocardiogram, and CMR) and a special test (called a pryophosphate scan) specifically to evaluate for ATTR-CM.  This is important as ATTR-CM is treated differently than HCM.

The research team is inviting participants to be included in a registry in order to look at the difference between the two diseases and how they are diagnosed.  This study's registry is a compilation of various cardiac images, lab tests, and medical histories of patients with HCM and ATTR-CM. If they choose to participate, they will be included in a  registry using the following information: clinical history, lab tests, echocardiogram, cardiac magnetic resonance imaging (CMR), and pyrophosphate scan.   We will look at this information to understand how often patients originally diagnosed with HCM were later diagnosed with ATTR-CM instead.

 

 

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Valvular Heart Disease


Transcatheter Aortic Valve Replacement to Unload the Left ventricle in patients with Advanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

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