Active clinical trials for "Heart Failure"

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization

The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.

Introduction： Muscle wasting is a serious complication that affects a large proportion of patients with heart failure (HF). Muscle wasting is a strong predictor of frailty and reduced survival in HF patients. Currently, standard treatments for slowing muscle loss in patients with HF are not available. The main intervention remains various types of physical activity programs. Telemonitoring is a promising strategy for improving heart failure outcomes by making it possible to monitor patients remotely. There are numerous examples of home-based exercise programs administered through telehealth services that have been beneficial for maintaining physical activity levels. These results highlight the potential utility of telehealth services for combatting sedentarism and muscle wasting among epidemic and post-epidemic phases. Objective： The purpose of this study is to evaluate the effect of a multi-component physical activity program based on home telemonitoring on patients with heart failure and muscle wasting. Methods： This study used an quasi-experimental study, two-group repeated measurement design. The experimental group received the Home-based exercise with telemonitoring and control group according to regular nursing care. Data were collected at baseline (T0), and post-tests will be conducted right after the intervention period (T1). Additionally, detraining effects will be measured 12 weeks after program cessation (T2) . Data were collected including demographic questionnaire, sarcopenia, cachexia assessment, clinical blood parameters from patient record, physical activity, loneliness, and quality of life. Scientific or Clinical Implication of the Expected Results： The study results can be used to design designated interventions and provide information for policymaking.

This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from the NK1R+ Mesenchymal stem cells as a therapy for chronic ischemic left ventricular dysfunction delivered using the investigational Helix transendocardial delivery catheter.

Early Feasibility Study of the FIRE1™ System in Heart Failure Patients to evaluate the feasibility and safety of implanting the FIRE1 system in stable HF patients

Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Despite major improvements in survival for VAD patients, quality of life and physical functioning measures have not seen significant improvements. This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.), and will be matched with the prospective interventional patients. The purpose of this study is to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients. Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.

Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.

The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.

First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in stable HF patients.

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.