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Heart Failure clinical trials

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NCT ID: NCT03190304 Completed - Heart Failure Clinical Trials

The Effect of Neprilysin (LCZ696) on Exercise Tolerance in Patients With Heart Failure

NEPRIExTol
Start date: June 14, 2017
Phase: Phase 4
Study type: Interventional

Studies with new drugs in the treatment of heart failure (HF), such as the combination of valsartan/sacubitril, also known as LCZ696, have demonstrated important clinical impact on the morbidity and mortality outcomes in HF population. However, the effect of LCZ696 on the pathophysiological mechanisms of HF such as exercise tolerance (peak VO2) and peripheral muscle blood flow is not known. Since LCZ696 is a new drug with promising effects on the treatment of HF, the objective of the present study will be to evaluate the effect of LCZ696 in patients with HF on: 1) peak VO2, 2) 6-minute walk test, 3) peripheral muscle blood flow, 4) muscle strength, and 5) body composition.

NCT ID: NCT03189654 Completed - Heart Failure Clinical Trials

Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure

Start date: July 1, 2017
Phase:
Study type: Observational [Patient Registry]

There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement. The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.

NCT ID: NCT03189368 Completed - Heart Failure Clinical Trials

Heart Failure Study of Multi-site Pacing Effects on Ventriculoarterial Coupling

HUMVEE
Start date: September 18, 2017
Phase:
Study type: Observational

To perform a comparative study of multi-site left ventricular pacing and cardiac resynchronization therapy effects on ventriculoarterial coupling and energy efficiency of the failing heart

NCT ID: NCT03187509 Completed - Heart Failure Clinical Trials

Weight-Based Torsemide Dosing in Subjects With Heart Failure

Start date: April 17, 2018
Phase: Phase 4
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 Completed - 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 Completed - Clinical trials for Heart Failure With Normal Ejection Fraction

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

IDENTIFY-HF
Start date: June 6, 2017
Phase:
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: NCT03185832 Completed - Heart Failure Clinical Trials

Heart Failure and Sudden Cardiac Death Japan Registry

HINODE
Start date: July 21, 2017
Phase:
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 Implantable Cardioverter-Defibrillator (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-Defibrillator (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 Pacing (PM/CRT-P) patient cohort. The all-cause mortality will be assessed in the non-implanted subject cohort.

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

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

ITISHOPE4HF
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. Patients will be provided telerehabilitation or advice on physical activity (standard care).

NCT ID: NCT03177447 Completed - Clinical trials for Heart Failure, Congestive

ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

Background: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. This pilot study engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom, health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models were used to assess baseline to week 24 longitudinal changes. The intervention was tailored to rural, older adults (age≥65) with advanced HF in reducing HF morbidity and improving patient and caregiver QOL and quality of care.

NCT ID: NCT03173157 Completed - Heart Failure Clinical Trials

Effect of Targeted Interventions to Improve Value Based Health Care for Inpatient Cardiology Patients

Start date: February 27, 2017
Phase: N/A
Study type: Interventional

The investigators hypothesize that a combined didactic and data feedback program presenting evidence based indications and in-hospital-charges for echocardiograms to inpatient cardiology team members will lead to increased health care value for patients on inpatient cardiology teams.