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Heart Failure, Systolic clinical trials

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NCT ID: NCT04217135 Recruiting - Clinical trials for Mitral Regurgitation

The Prognostic Impact of Using High-dose Hydralazine in Severe Systolic Heart Failure With Hemodynamically Significant Mitral Regurgitation

Start date: January 1, 2017
Phase: Phase 4
Study type: Interventional

Background: Severe systolic heart failure would be complicated with low cardiac output and high left ventricular filling pressure and the clinical presentations would be low blood pressure, poor peripheral perfusion, and pulmonary edema. Severe systolic heart failure with hemodynamically significant mitral regurgitation brings even more challenged since the obvious elevation of left atrial pressure induces more pulmonary congestion and backward flow of regurgitation in cases with already low cardiac output and poor peripheral perfusion complicates more severe of low cardiac output. Surgical interventions in those cases aren't strongly recommended due to very high operation risk. In the era of lack of nitroprusside in Taiwan (more than 7 years), hydralazine, a direct vasodilator, is a potential substitute for treatment of those cases. The advantages of hydralazine include 1) different dosage forms are available (10 mg, 25 mg, and 50 mg); 2) short half-life makes it reaching steady blood concentration in short period and allow to up- titrate rapidly and also recover fast while adverse reaction occurs; 3) it is much cheaper than other evidence-based medications. In this study, the investigators try to use rapid up-titration of hydralazine to maximal tolerable dose, almost up to 300-400 mg per day, combined with other evidence-based medications in cases with left ventricular ejection fraction less than 35% and mitral regurgitation severity more than moderate degree and assess the prognostic impact. Objective: Four hundred of patients with severe systolic dysfunction and hemodynamically significant mitral regurgitation, who were admitted for intensive care unit for acute decompensated heart failure, will be enrolled and the participants will be divided into two groups according 1 to 1 randomization process. Control group will receive conventional treatment with tolerable maximal dose of evidence-based medications and study group will use hydralazine with rapid up-titration, if no clinical adverse responses were noted, following by or simultaneously using evidence-based medications. The end-points include in- hospital mortality, 3-year all-cause mortality and heart failure rehospitalization. During follow-up period, any adverse response of high-dose hydralazine including lupus-like syndrome and arthritis will be monitored.

NCT ID: NCT04201015 Recruiting - Clinical trials for Heart Failure, Systolic

Optimising Pacing for Contractility 2

OPT-cont 2
Start date: June 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over and a small parallel group feasibility study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled 3-arm parallel group trial whether optimal programming versus standard rate-response programming versus no rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity and what the mechanisms of this might be. 400 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test, complete quality of life questionnaires and be offered the opportunity to participate in a series of mechanistic substudies. They will then be randomised to optimal rate-response settings, standard rate response settings or no rate-response settings and followed up at 6 months at which point the tests will be repeated.

NCT ID: NCT04179643 Recruiting - Heart Failure Clinical Trials

NAN-101 in Patients With Class III Heart Failure

NAN-CS101
Start date: November 20, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic congestive heart failure will be enrolled until up to 12 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).

NCT ID: NCT04083690 Recruiting - Clinical trials for Heart Failure, Systolic

Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients

METEOR-CRT
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.

NCT ID: NCT03830957 Recruiting - Heart Failure Clinical Trials

Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker

Start date: November 26, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart rate prior to coronary CT angiography in patients with advanced heart failure.

NCT ID: NCT03797001 Recruiting - Inflammation Clinical Trials

Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2

REDHART2
Start date: January 4, 2019
Phase: Phase 2
Study type: Interventional

REDHART2 is a randomized, double-blinded, placebo-controlled trial to determine the effects of Anakinra on peak aerobic exercise capacity measured with a cardiopulmonary test after 24 weeks in patients with recently decompensated systolic heart failure and increased systemic inflammation.

NCT ID: NCT03764722 Recruiting - Clinical trials for Systolic Heart Failure

Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations

Start date: August 1, 2018
Phase: Phase 4
Study type: Interventional

Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure. Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a negative financial impact on the health care system. Currently, studies are being conducted on the efficacy of levosimendan in the prevention of heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary results suggest a reduction in the incidence of exacerbations of heart failure. Thanks to the clinical trial planned in the Department of Cardiology of the Biziel Hospital with repeatable use of levosimendan, it is possible to determine the benefits of this method of treatment more accurately.

NCT ID: NCT03640000 Recruiting - Clinical trials for Heart Failure, Systolic

Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy

Impel
Start date: January 2015
Phase: N/A
Study type: Interventional

This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.

NCT ID: NCT03573869 Recruiting - Atrial Fibrillation Clinical Trials

Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

AFICHE
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month. A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.

NCT ID: NCT03553303 Recruiting - Clinical trials for Heart Failure, Systolic

Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin

Start date: October 16, 2018
Phase: Phase 4
Study type: Interventional

The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.