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Heart Failure clinical trials

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NCT ID: NCT03091998 Withdrawn - Heart Failure Clinical Trials

Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support

Start date: September 30, 2017
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT03032211 Withdrawn - Heart Failure Clinical Trials

Optimal Balance Alfapump® System Feasibility Study

Start date: December 31, 2017
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT03032081 Withdrawn - Heart Failure Clinical Trials

High Intensity Interval Training in Heart Failure

Start date: March 2, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02870647 Withdrawn - Clinical trials for Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)

Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients

Start date: n/a
Phase: Phase 4
Study type: Interventional

Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.

NCT ID: NCT02735993 Withdrawn - Clinical trials for Coronary Artery Disease

Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells

Start date: October 2014
Phase: N/A
Study type: Observational [Patient Registry]

This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection.

NCT ID: NCT02721511 Withdrawn - Clinical trials for Acute Decompensated Heart Failure

A Study to Investigate the Safety and Efficacy of a Novel Furosemide Regimen

Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a, prospective, single center, open-label, pilot study to evaluate the safety and efficacy of the subcutaneous administration of a novel furosemide formulation. The results of this pilot study will be reviewed to determine the safety of the subcutaneous treatment regimen and to evaluate patient selection criteria for possible at home treatment. The intent is to conduct a future follow on study looking at the feasibility of at home treatment of patients referred to a hospital for treatment of fluid overload.

NCT ID: NCT02624960 Withdrawn - Heart Failure Clinical Trials

Safety and Performance of the AccuCinch® System

Start date: September 2016
Phase: N/A
Study type: Interventional

This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral regurgitation in symptomatic adult patients with mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.

NCT ID: NCT02599857 Withdrawn - Heart Failure Clinical Trials

The Effects of a CONCOR Smartphone Application

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Life expectancy of children with congenital heart disease (CHD) has increased dramatically during the past years, due to the successes of cardiac surgery. Nearly all of these children with CHD can be operated at young age and more than 90% reach adulthood. However, many adults with CHD are life-long affected by cardiac events, particularly arrhythmias and heart failure, putting them at risk of premature death. These events have a large impact on quality of life of patients and their families and merit life-long hospital visits in a medical center specialized in adult CHD. Especially for adults with CHD patient care with a smartphone is suited because of their young age and chronic condition. So far, data are lacking on smartphone interventions in patients with CHD.

NCT ID: NCT02568514 Withdrawn - Diabetes Clinical Trials

Study of the Effect on Clinical Outcomes Using Secure Text Messaging

Start date: August 2016
Phase: N/A
Study type: Interventional

In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.

NCT ID: NCT02511912 Withdrawn - Clinical trials for Chronic Heart Failure

Reducing Lung Congestion Symptoms Using the V-wave Shunt in Advanced Heart Failure

Start date: March 2017
Phase: N/A
Study type: Interventional

The objective of this study, is to assess the safety and performance of the V-Wave System when implanted in patients with severe chronic heart failure.