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Heart Failure clinical trials

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NCT ID: NCT03187509 Not yet recruiting - Heart Failure Clinical Trials

Weight-Based Torsemide Dosing in Subjects With Heart Failure

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

This study will be a randomized open-label pilot study. The purpose of the study is to compare standard of care outpatient heart failure management versus a weight based torsemide regimen. Subjects admitted to the hospital for heart failure exacerbation will be randomized upon discharge to either standard of care outpatient heart failure management or a weight based torsemide regimen. Those subjects randomized to standard of care therapy will be prescribed a daily fixed dose of a loop diuretic at hospital discharge and have a follow-up appointment within one week of discharge. All management decisions including loop diuretic type, dose and frequency will be made at the discretion of the subject's personal physician. Those randomized to an individualized weight based torsemide regimen will be prescribed a dose of torsemide upon hospital discharge based on a prespecified algorithm. These subjects will then undergo physician-subject phone encounters three times a week where the subject's torsemide dose will be modified based on the prespecified algorithm which incorporates current symptoms and weight. Primary end-point will be an unbiased estimate of 30-day all cause readmission rates. Secondary end-points include incidence of acute kidney injury, changes in brain natriuretic peptide levels from baseline and a preliminary estimate of the effect size and feasibility of a weight-based torsemide regimen intervention in order to plan a future larger study.

NCT ID: NCT03187470 Recruiting - Clinical trials for Heart Failure,Congestive

Left Ventricular Dyssynchrony in Multipole Pacing

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

Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator.

NCT ID: NCT03186833 Recruiting - Clinical trials for Heart Failure With Normal Ejection Fraction

The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.

Start date: June 6, 2017
Phase: N/A
Study type: Observational

The study addresses the hypothesis that a gradual build-up in arterial resistance and microvascular endothelial dysfunction due to common comorbidities such as hypertension and diabetes mellitus, on top of age related vascular and cardiac changes (mainly fibrosis and hypertrophy), is responsible for HFpEF. The HFpEF syndrome is commonly seen in elderly subjects (often females) with hypertension and diabetes. The investigators will investigate the vascular function, cardiovascular performance and myocardial fibrosis in different cohorts of subjects to try and prove this hypothesis. There will be 5 groups of subjects, all ≥ 70 years of age, as follows: A) Normal healthy volunteers without major comorbidities including hypertension or diabetes B) Patients with hypertension only (without diabetes mellitus) C) Patients with hypertension AND diabetes mellitus D) Patients with HFpEF. E) A parallel group of patients with Heart Failure with reduced Ejection Fraction (HFrEF) group. Arterial resistance measured by pulse wave velocity will be the primary measure and will be compared between groups A to D. A separate comparison will be made between groups D and E. Other secondary measures will focus on endothelial function (Laser Doppler measurements) and other cardiovascular performance measures (peak VO2 by CPEX, 6-minute walk distance). Bloods samples will be taken for NT-proBNP, high sensitivity Troponin T, Galectin 3 and also stored for testing later for vascular biomarkers.

NCT ID: NCT03186404 Not yet recruiting - Cancer Clinical Trials

Statins for the Primary Prevention of Heart Failure in Patients Receiving Anthracycline Pilot Study

Start date: July 2017
Phase: Phase 2
Study type: Interventional

Anthracycline (AC) chemotherapy has substantially reduced the mortality rate from several common cancers globally. Unfortunately, AC treatment is associated with up to 19% risk of heart failure (HF). Current standard of care for preventing AC induced HF (AIHF) is cardiac surveillance followed by initiation of treatment once HF is diagnosed. With this approach 89% of patients fail to recover heart function and 46% will experience adverse cardiac events. Therefore there is a need for effective preventive therapy to reduce the risk of AIHF. Based on small human studies, animal studies, and our own pilot data, statins are an ideal class of drug for this purpose. We will conduct a pilot double blinded, placebo controlled, randomized controlled trial to assess whether pre-treatment with statins before AC can prevent heart dysfunction. Eligible patients with cardiovascular risk factors scheduled to receive AC will be recruited. They will be randomized to statin therapy or placebo and followed until the end of cancer treatment. Primary outcome is the difference in cardiac MRI-determined left ventricular ejection fraction between pre-AC and end of treatment.

NCT ID: NCT03185832 Not yet recruiting - Heart Failure Clinical Trials

Heart Failure and Sudden Cardiac Death Japan Registry

Start date: June 2017
Phase: N/A
Study type: Observational

The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States. Selected Subject Cohorts: 1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo ICD device treatment. 2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-D device treatment. 3. Selected subject cohort who are clinically expected to require >40% right ventricular pacing with a left ventricular ejection fraction (LVEF) <50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades). 4. Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF <35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P. The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort. The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the PM/CRT-P patient cohort. The All-cause mortality will be assessed in the non-implanted subject cohort.

NCT ID: NCT03184311 Not yet recruiting - Clinical trials for Heart Failure With Normal Ejection Fraction

High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction

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

This study investigates the effects of a 12-week high-intensity interval training (HIT) on exercise tolerance, functional status and quality of life in patients with chronic heart failure with preserved ejection fraction (HFpEF), in comparison to a control group continuing to undergo usual care.

NCT ID: NCT03183817 Not yet recruiting - Heart Failure Clinical Trials

Person-centred Care at Distance

Start date: June 12, 2017
Phase: N/A
Study type: Interventional

The goal of the research project PROTECT is to translate the person-centred care (PCC) principles into an eHealth context. A developed PCC eHealth platform will be used as a tool to identify patients´ resources to enhance coping and living with their chronic illness by means of a dialog and partnership with staff and relatives. The PCC eHealth platform will not replace, but instead be used as add on treatment to usual care (guideline directed care).

NCT ID: NCT03183323 Recruiting - Clinical trials for Chronic Kidney Diseases

Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure

Start date: June 8, 2017
Phase: N/A
Study type: Interventional

ITISHOPE4HF is a randomized controlled trial of telerehabilitation in a heart failure population. The goal is to evaluate if a home-based telerehabilitation project can increase physical activity in heart failure patients. Patient will be provided telerehabiliation or advice on physical activity (standard care).

NCT ID: NCT03183011 Recruiting - Clinical trials for Heart Failure, Systolic

Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

This study is evaluating how MRI after CRT can provide key insights regarding LV function, structure, and mechanics resulting from CRT in patients with or without LV scar and inform optimal pacing strategies. The expected accurate and reproducible response assessment with cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and the insights from the post-CRT MRI promise to improve implementation of CRT.

NCT ID: NCT03180450 Not yet recruiting - Heart Failure Clinical Trials

The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)

Start date: July 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients