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The purpose of this study is to determine the efficacy and feasibility of using a smartphone application to monitor symptoms and weight in patients with advanced heart failure.
Heart failure is a clinical syndrome marked by breathlessness, even at low levels of exertion, general fatigue, and fluid retention and is estimated to affect 5.1 million people in the United States. Heart failure with preserved ejection fraction (HFpEF) means that the heart pumps enough blood to the body, but patients still have terrible symptoms. It is estimated to account for about 50% of all heart failure cases. Experts agree that impaired filling of the heart, perhaps due to "stiffness" of the heart muscle itself, critically underlies HFpEF. There is currently no clinical technique for measuring heart muscle (myocardial) stiffness; the very definition of "myocardial stiffness" remains poorly established. Consequently, the ability to study the mechanisms that underlie HFpEF is virtually non-existent, and limited treatment options will persist without significant advances. The objective of this project is to use an Equilibrium-Material-Stability (EMS) framework that couples patient-specific clinical MRI and heart pressure data in a computational model of the heart to diagnose changes in myocardial stiffness. The central hypothesis is that the new EMS framework for understanding the mechanisms of diastolic dysfunction in HFpEF will be more sensitive and outperform currently available approaches.
This pilot, feasibility study evaluates the efficacy of sacubitril-valsartan (Entresto) versus usual anti-hypertensive medications in patients with left ventricular assist devices (LVAD). It also measures diurnal blood pressure variations in the context of continuous flow physiology.
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
RESPOND-HF is a prospective, multi-center, non-significant risk pilot study with cross-over design. The purpose of the study is to investigate if rate adaptive pacing has the potential to provide benefit to HF patients with preserved ejection fraction, referred to as HFpEF patients. Findings from this pilot study may be used to guide subsequent efforts to design and conduct a prospective, randomized, multi-center pivotal trial powered to show improvement in patient outcomes.
This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.
The worldwide use of left ventricular assist devices (LVAD), which is mechanical device to improve hemodynamic function, has improved the outcomes of severe heart failure (HF) patients leading to the continued annual increase in the number of LVAD implantations. However LVAD support still results in major complications such as renal failure or gastrointestinal bleeding. The investigators hypothesize that such major complications may be due to endothelial dysfunction induced by the lack of pulsatility, which may be improved by an innovative designer natriuretic peptide, CD-NP. They have demonstrated its favorable actions in animal models as well as humans, and tested its safety in LVAD patients. They hypothesize that CD-NP will have renal and endothelial protective actions through its receptor GC-A and GC-B. Thus, the investigators will test their hypothesis with a highly translational approach to examine CD-NP's role in endothelial and renal protection. The aim is to determine safety and tolerability together with cGMP activating, neurohumoral modulating and renovascular protective properties of chronic subcutaneous delivery of CD-NP compared to placebo in stable LVAD patients for 3 days.
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients.
1. Summary of Clinical Investigation A summary of the clinical investigation is provided below and includes the primary objective of the study, the safety and feasibility endpoints, the number of subjects to be enrolled, the study duration, the subject follow-up and the inclusion/exclusion criteria. 1. Primary Objective The primary objective of the study is to evaluate the safety and feasibility of the alfapump® System indication for use in the management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients who have an eGFR of > 15 to < 60 mL/min/1.73m2. 2. Study Endpoints 1. Primary Safety Endpoint The primary safety endpoint will be an assessment of the occurrence of adverse events (AEs) and serious adverse events (SAEs) related to: 1. Surgical implant of the alfapump® 2. Device malfunctions 3. Dialysate infusion 2. Secondary Safety Endpoints The secondary endpoint will be an assessment of: 1. Time to first hospitalization related to fluid management after the activation of the alfapump® System and initiation of dialysate infusion has occurred 2. Rate of occurrence of re-hospitalizations related to fluid management 3. All-cause mortality 3. Assessment of Feasibility for Fluid Management in Heart Failure Indication The feasibility of the alfapump® System for management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients with renal dysfunction will be assessed by the net fluid balance as measured by the ability of the alfapump® System to move more fluid to the bladder than dialysate instilled.
The investigators will assess the efficacy and safety of utilizing high-intensity interval training in stable heart failure patients on functional outcomes. Specifically, an assessment of baseline peak oxygen uptake and peak cardiac output will be assessed before and 8 weeks after intense interval training. Measurements of quality of life will be assessed before and after training as well as the number of arrhythmic events before and after training. The control group will be a group that will follow a moderate exercise training protocol over a similar period.