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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.


Monitoring Heart Failure Patients using Heart Rate Variability measured by the Apple Watch

This is a pilot/feasibility study on the accuracy of HRV measured by the Apple Watch on the clinical status of patients admitted for acute heart failure decompnsation. We hypothesize that there will be a statistically significant improvement in the HRV that correlates clinically over the course of hospitalization. Meaningful findings from this study will strengthen the potential for a telemonitoring system where HRV measured remotely from home using wearable devices like Apple Watch can help physicians monitoring their health and intervene accordingly.


CRD_973 SyncAV Post-Market Trial

This study will examine how effective the SyncAV feature of Abbott’s cardiac resynchronization therapy device is in treating 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 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. 


Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial

This is a Prospective, multicenter, randomized, parallel-controlled, open-label two arm trial with an adaptive design. Eligible subjects will be randomized in a 1:1 ratio to PCI with Impella CP® (Intervention Group) versus standard of care PCI with or without IABP (Control Group). Approximately 1252 subjects will be randomized in a 1:1 ratio to PCI + Impella vs. PCI ± IABP.

The objective is to demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, MI or hospitalization for cardiovascular causes at 3-year follow-up.

All subjects will have follow-up for 3 years after randomization. The primary endpoint will be assessed after the last randomized patient reaches 1-year follow-up.

Eligible subjects are those with a chronic coronary syndrome (CCS) or NSTEMI with LVEF  40% or STEMI ≥24 hours and <30 days after symptom onset with LVEF 30% in whom complex PCI is planned after heart team discussion, without any study Exclusion Criteria and who provide informed written consent for participation in the Trial. Prior to randomization, all subjects will undergo baseline transthoracic echocardiography, QoL assessment, 6MWD testing (if able to ambulate). Randomization will take place in the Cardiac Catheterization Lab. Prior to randomization in the Cath Lab, the PCI operator will declare 1) the intended revascularization plan regardless of the use of hemodynamic support (including vessels/lesion, staging and intended IABP use); 2) the intent to use (or not use) IABP if randomized to the Control arm; 3) the planned use of right heart catheterization either within or not within a formal sub-study or not at all. Patients will then be randomized to PCI with Impella CP or standard of care PCI (± IABP),treatment of patients and discontinuation of hemodynamic support will be based on Protocol recommendations and standard of care at the hospital site, but Impella removal in the Cath lab is mandated.


Implantation of the HeartMate 3 in Subjects with Heart Failure using  Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT)

This study is looking at patients who will be receiving the HeartMate3 Left ventricular assist device and its insertion based off of an incision technique aside from full median sternotomy.


Prospective Multi-Center Randomized Study for Evaluating the EVAHEART2 Left Ventricular Assist System: the COMPETENCE Trial

The purpose of this randomized study is to evaluate the safety and effectiveness of EVAHEART 2 Implantable Left Ventricular Assist System (EVA2 LVAS) by demonstrating non-inferiority to HeartMate 3 when used for the treatment of advanced, refractory, New York Heart Association Class IV heart failure.


Taking Care of Us: A dyadic intervention for heart failure

The proposed dyadic intervention will be one of the first to target the outcomes of both the HF patient and their spouse care partner simultaneously through a team-based intervention centered on shared appraisal, collaboration, communication and confidence to promote optimal dyadic health. The proposed study is, therefore, significant in addressing an important gap. Our study will determine the feasibility, acceptability and clinical meaningfulness of the Taking Care of Us program, providing vital information needed to move closer to our long-term goal to successfully translate this program into multiple delivery modalities (for maximum reach) and inform clinical practice. Results of this study will provide vital information to move us closer to translating successful programs into clinical practice and shed important light on whether, for whom, and how the Taking Care of Us program benefits both members of the HF care dyad


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.


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 (


Food As Medicine in Heart Failure

Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and mortality. Therefore nutritional interventions to improve dietary quality and prevent malnutrition development may represent an effective strategy to improve HF-related health status and survival outcomes. To date, there are no large clinical trials investigating the efficacy of ‘food as medicine’ to improve morbidity and mortality for patients with heart failure with reduced ejection fraction (HFrEF). We plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) to patients with HFrEF and malnutrition. We hypothesize that home delivery of MTMs will be feasible, well-tolerated and achieve a high degree of satisfaction for patients with HFrEF. The first phase of the proposed pilot study will asssign participants to a 12-week MTM phase only. The second phase is a randomized crossover trial, in which each subject receives a 12-week standard of care phase with self-directed dietary intake and a 12-week MTM dietary intervention phase, with a 4-week washout period between the two phases. Meals will be designed, prepared and delivered by our community based organized partner, Community Servings. We will measure HF-related health status, functional capacity, and biomarkers of heart failure and nutritional status before and after each study phase. The proposed study will facilitate a larger future randomized trial of MTM for patients with HFrEF and malnutrition, powered to examine the impact on HF hospitalizations and mortality.


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.


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. 


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