Active clinical trials for "Heart Failure"

Met-PEF will be a randomized, double-blind, placebo-controlled trial to examine the effects of 20 weeks of 1500 mg/day of metformin on physical function, quality of life (QOL), microbiome diversity, leaky gut, and systemic inflammation in patients with 80 older patients with heart failure with preserved ejection fraction (HFpEF).

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

The present study is testing in a combined design to types of drugs in patients with chronic heart failure: 1) Hydralazine in combination with isosorbide dinitrate (BiDil) and 2) Metformin hydrochloride. The study is double blind, placebo controlled. The first hypothesis is that hydralazine in combination with isosorbide dinitrate can reduce mortality and hospitalization with worsening heart failure. The second hypothesis is that treatment of underlying insulin resistance/ type 2 diabetes with metformin in heart failure patients with moderately to severely reduced LVEF can reduce mortality and cardiovascular hospitalizations. Among secondary endpoints are reduction in new-onset diabetes in heart failure patients with insulin resistance and diabetes risk profile and patient safety.

This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for Destination Therapy.

This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.

The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is associated with increased systemic inflammation. Previous studies have demonstrated increased levels of cytokines such as C-reactive protein (CRP), interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-10 (IL-10) and Tumor Necrosis Factor alpha (TNFα) in patients with heart failure (HF). Increased activity of sympathetic nervous system in ADHF is linked to inflammation. Previous anti-inflammatory drug therapies in HF have demonstrated no significant impact on cardiovascular outcomes. Low-level vagus nerve stimulation (LLVNS) is a non-invasive way to modulate autonomic tone and thereby inflammation. Vagal nerve stimulation is thought to increase the parasympathetic activity and suppress the sympathetic activity. Clinical studies of vagal stimulation in chronic HF have been negative. Recent experimental and clinical data suggest that low level tragus nerve stimulation (LLTNS) may produce the same desired neuromodulator effect compared to LLVNS. It is however unknown if LLTNS in ADHF will directly lead to a reduction in the levels of pro-inflammatory cytokines (CRP, IL-1, IL-6 and TNF-α) and an increase in the level of anti-inflammatory marker IL-10. heart rate variability may also be abnormal in ADHF. The objective of this proposal is to determine the impact of LLTS on inflammatory cytokines, heart failure biomarkers(Pro BNP) and HRV in patients with ADHF.In addition we will study the impact on dyspnea resolution and change in renal function during hospitalization. Patients will be randomized to either active or sham stimulation (2 hours daily). Serum collected will (post-admission and discharge day) will be used for cytokine measurement. We will also measure daily ECG to assess HRV and patient assessed dyspnea scale.This investigation will likely establish the first evidence of the effects of LLTS on the suppression of inflammation and improvement in dyspnea, natriuretic peptides, renal function and HRV in patients presenting with ADHF.

Heart failure (HF) is currently considered a common pathology, with 15 million adults in Europe and 26 million worldwide. The American Heart Association (AHA) estimates that their number will increase by 25% by 2030. In France, HF affects more than one million people. Because of the repeated hospitalizations of this disease, it is considered a costly pathology and with a high mortality rate (23.000 deaths per year in France). Moreover, HF is a severe pathology that affects the quality of life of patients and their families. Treatment and medical follow-up are required. A cardiac rehabilitation program is also a primary indication according to the latest recommendations and repositories in Cardiology. Various studies show that "Interval Training" exercise program improves VO2 peak compared to a "continuous" program, which constitutes a major prognostic factor in the population of heart failure. However, it is sometimes a difficult program to offer to more deconditioned patients as it requires reaching powers around 80% - 95% of its maximum exertion capacity. So, a variant of the interval training is offered, called Progressive Interval Training (PIT), based on the same model as the conventional interval training (CIT), but with an increasing power and breathing threshold, so that the patient can adapt gradually. The hypothesis is that PIT could improve VO2 peak better than CIT in cardiac rehabilitation program. Therefore, study the benefits of PIT training to improve the conditioning and quality of life of patients with chronic heart failure will be studied.

The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

The purpose of this study is to compare intravenous furosemide (125 to 250 mg), isolated or in combination with hypertonic saline solution (2.4% to 3.6%) in the outpatient heart failure patient. The hypothesis is that the combination therapy will increase the diuresis volume at 3 hours and improve congestion parameters at 7 days.