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Heart Failure, Systolic clinical trials

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NCT ID: NCT04636892 Recruiting - Clinical trials for Coronary Artery Disease

Evaluating Infrasonic Hemodynography

Start date: January 4, 2021
Phase: N/A
Study type: Interventional

This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.

NCT ID: NCT04611594 Recruiting - Clinical trials for Heart Failure, Systolic

Fluid Restriction in Patients With Heart Failure

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

There is a concept increasingly consolidated by clinical evidence that at each hospitalization due to HF decompensation there is a substantial loss of quality of life, which is associated with an initial period of great clinical vulnerability, with high rates of rehospitalization and an increased risk of death. The non-pharmacological measures that are widely practiced and recommended for HF patients, such as fluid restriction, specially at the first 30 days after hospital discharge, still lack clearer evidence of their therapeutic efficacy.

NCT ID: NCT04589065 Suspended - Heart Failure Clinical Trials

SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)

Start date: September 2024
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate to severe heart failure and is at least in part due to heart failure and it not responding to standard medical therapy. The SCD is a cartridge used with a commercial hemodialysis unit. Participants will be enrolled in the clinical trial once eligibility is confirmed. In addition to clinical assessments and laboratory testing participants will have surface echocardiograms during the trial. The SCD treatment will take place for 4 hours on day 1, 3, and 5 while on hemodialysis.

NCT ID: NCT04570865 Not yet recruiting - Clinical trials for Heart Failure, Systolic

Dapagliflozin And Pulmonary Artery Hemodynamics in Heart Failure With Reduced Ejection Fraction Patients With CardioMEMS®

DAPA-MEMS
Start date: December 1, 2020
Phase: Phase 4
Study type: Interventional

The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

NCT ID: NCT04529577 Recruiting - Clinical trials for Heart Failure, Systolic

His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction

HIS-PrEF
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.

NCT ID: NCT04528004 Recruiting - Clinical trials for Heart Failure, Systolic

Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure

NRII
Start date: September 26, 2020
Phase: Early Phase 1
Study type: Interventional

Preliminary animal studies by ourselves and others suggest that the dietary supplement, nicotinamide riboside (NR), may improve cardiac function in heart failure (HF) by increasing cellular levels of its metabolite, nicotinamide adenine dinucleotide (NAD+, NADH). This Study will address a key gap in current knowledge by assessing the mechanisms through which raising blood and myocardial NAD+ levels in humans mediates changes in mitochondrial function, protein and epigenetic modifications, as well as inflammation. Human myocardium will be obtained after 4-14 days of oral NR supplementation from advanced heart failure patients undergoing elective left ventricular assist device (LVAD) implantation. Positive results would provide evidence to proceed with further studies of NR as a mitochondria-targeted metabolic therapy in heart failure.

NCT ID: NCT04522609 Recruiting - Sarcopenia Clinical Trials

Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

Start date: September 2020
Phase: N/A
Study type: Interventional

Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. It is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. In patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of heart failure management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity. In this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.

NCT ID: NCT04468529 Active, not recruiting - Clinical trials for Chronic Systolic Heart Failure

Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure

Start date: December 10, 2020
Phase: Phase 3
Study type: Interventional

A multi-center, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the effect of injectable Neucardin on the heart function in male patients with NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml, NYHA II-III chronic systolic heart failure, and to confirm its efficacy and safety.

NCT ID: NCT04420481 Completed - Clinical trials for Heart Failure, Systolic

Growth Hormone in Ischemic Heart Failure

Start date: April 28, 2004
Phase: Phase 3
Study type: Interventional

In a double-blind, placebo-controlled trial, we randomly assigned 37 patients (mean age 66 years; 95% male) with ischemic heart failure (HF) (ejection fraction (EF) < 40%) to a 9-month treatment with either recombinant human GH (1.4 mg every other day) or placebo, with subsequent 3-month treatment-free follow-up. The primary outcome was change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR). Secondary outcomes comprised changes in cardiac structure and EF. Prespecified tertiary outcomes included changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP).

NCT ID: NCT04342832 Recruiting - Heart Failure Clinical Trials

Cryoballoon Ablation Versus Medical Therapy in Patients With Heart Failure and Atrial Fibrillation

RACE-8-HF
Start date: July 16, 2020
Phase: N/A
Study type: Interventional

Rationale: Atrial fibrillation (AF) and heart failure (HF) can cause each other and sustain each other. Combined, the two diseases negatively influence each other's prognosis and lead to higher mortality. Studies in HF patients in which the AF burden is reduced by AF ablation show promising results toward improved prognosis, but so far only one randomized trial is conducted that focused on major clinical endpoints. As the selected patients in this trial were not representative for the entire population and its ablation method varied from patient to patient, it is the aim of the present study to confirm that early invasive therapy consisting of a strict pulmonary vein isolation (PVI) protocol using cryoballoon therapy has positive effects on hard clinical endpoints in a wider variety of patients in the HF population. Furthermore, there are no studies which compare cost-effectiveness of an early invasive strategy in this patient category. The investigators expect that avoided hospitalizations and healthcare resource utilizations lead to lower costs in the AF ablation group, despite initial higher costs of the procedure. Objective: To compare outcome and cost-effectiveness of early AF ablation by PVI using cryoballoon therapy with standard (medical) therapy in patients with heart failure with reduced ejection fraction. Study design: Multicenter, randomized, open label clinical trial. Study population: Symptomatic adult patients with heart failure with reduced ejection fraction (<40%) and paroxysmal or persistent AF. Intervention: AF ablation (PVI) using cryoballoon therapy. Outcome measures: The primary endpoint is a combined endpoint of all-cause mortality, unplanned cardiovascular hospitalization, and stroke (time-to-event analysis). Secondary endpoints of the trial are: - A combined endpoint of mortality, number of unplanned cardiovascular hospitalizations, and stroke (recurrent-event analysis); - A hierarchical endpoint of mortality, unplanned cardiovascular hospitalizations, stroke, and HF complaints; - Cost-effectiveness. Key exploratory endpoints include individual components of the combined endpoints, days alive out of the hospital, hospitalizations for heart failure, recurrence of atrial arrhythmia, and quality of life.