Heart Failure Clinical Trials

Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. The investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration. The study has now been registered on ClinicalTrials.gov, despite its initiation on July 23, 2015, as registration was not mandated at the original study site, the University of Pittsburgh Medical Center. However, following the transfer of the study to Weill Cornell Medicine, adherence to institutional requirements necessitated its registration on ClinicalTrials.gov. Read Less

The goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to standard of care on heart and lung function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with chronic kidney disease. Read Less

This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy. The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific. Read Less

The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training. Read Less

Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings. Read Less

End-stage heart failure (HF) is a progressive illness with a mortality rate similar to most advanced cancers.Roughly 5% of patients with HF have end-stage disease that is refractory to medical therapy (stage D heart failure). When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, or elect a palliative approach, inotropes are frequently used to improve hemodynamics through an increase in cardiac output and reduction in filling pressures. While inotropes provide profound symptomatic relief, these benefits are accompanied by significant risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is, therefore, an urgent need to develop strategies to reduce the dose or duration of inotrope use in the management of patients with stage D of HF. Read Less

This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility. Read Less

The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction. Read Less

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center involves four separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Projects 2 and 4) and coronary heart disease (CHD, Project 3). The first three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. Projects 1-3 also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 2 of the ACHIEVE GREATER Center. Read Less

ACHIEVE-P4: PATHFINDER is a randomized, blinded clinical trial of portable air cleaners (PAC) provided at the time of hospital discharge to Heart Failure (HF) patients. It will be carried out at Henry Ford Hospitals. This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A). The ACHIEVE GREATER Center involves several separate but related projects that aim to prolong lifespan among Detroit, MI and Cleveland, OH, for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Projects 2 \& 4) and coronary heart disease (CHD, Project 3). The present study is Project 4 (Aim 1) a randomized clinical trial titled: Portable Air cleaners to Treat Heart Failure and Negate Disparities of Environment and Race (PATHFINDER), of the ACHIEVE GREATER Center. Project 4 is a randomized, double-blind, parallel limb trial of 400 patients with hospitalized HF who will be provided active PAC vs sham at discharge from HFH. Participants will receive two PACs at discharge and an indoor PM2.5 sensor. PACs will be randomized to either active PAC with HEPA filters or sham PAC without HEPA filters. Researchers will compare the following outcomes of the two groups (more outcomes below in Outcome Measures section): 1. Change in NTproBNP from baseline to 90 days 2. Home PM2.5 levels from baseline to 90 days 3. Clinical events such as death and hospitalization will be monitored Read Less

The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise. Read Less

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment. Read Less