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Heart Failure


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 pumpt). 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 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. 

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A phase III randomised, 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 beind 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 failurea nd 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 pumpt). 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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