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Heart Failure clinical trials

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NCT ID: NCT02772146 Terminated - Heart Failure Clinical Trials

A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure

Start date: May 11, 2016
Phase: N/A
Study type: Interventional

A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours. The device will be connected to an existing, standard PD catheter that the patient will be using routinely prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study). The patient will be hospitalized for observation during the test day and during the night following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood glucose concentrations as well the patient's acceptability and tolerance of the wearable device will be evaluated.

NCT ID: NCT02769351 Terminated - Acute Heart Failure Clinical Trials

Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration

GENTLE-UF
Start date: December 3, 2015
Phase:
Study type: Observational [Patient Registry]

In patients with advanced volume overload, minimally invasive ultrafiltration treatment in the acute phase can have a positive effect on clinical outcome. The aim is to collect treatment data in the context of a prospective registry of the safety and performance of minimally invasive ultrafiltration. The data will be recorded via an electronic case report form (eCRF); the eCRF runs on a server located in Germany and complies with current data protection regulations. It is intended to include about 300-500 patients with advanced volume overload at a minimum of 10 sites. In addition, data on a disease management programme (in-body measurement and home monitoring) will be recorded in up to 40 of these patients. The treatment data from each patient will be recorded over 12 months. An interim analysis will be performed after 150 patients have been observed for 6 months. The knowledge about ultrafiltration in volume overload obtained from the registry, in some cases in combination with a disease management programme, is intended to improve the body of evidence. In addition, the data will be used for hypothesis generation.

NCT ID: NCT02762825 Terminated - Clinical trials for Heart Failure, Diastolic

Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

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

Patients with HFpEF suffer from exercise intolerance, increased risk for hospitalization and mortality, and poor QOL. Unlike patients with HFrEF, no drug or device therapies appear to be consistently beneficial in treating these problems. However, increasing evidence suggests that exercise training is effective for both partially reversing exercise intolerance and improving quality of life in these patients. Most such trials to date have been conducted in controlled research setting, versus integrating these patients in to a standard CR program. Also, since functional capacity is related to outcomes in these patients, exercise strategies aimed at further improving fitness are warranted. One such strategy is using higher intensity interval training (HIIT) in the CR setting, a strategy shown to be effective in patients with other types of CVD. This project is designed to test the feasibility of incorporating these patients into the CR setting, and training them using a methodology (i.e., HIIT) already shown to yield (in other patients with CVD) greater gains in fitness when compared to what was achieved using standard MCT alone.

NCT ID: NCT02757976 Terminated - Clinical trials for Heart Failure, Left Ventricular Dysfunction

Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial

RAFT-LVendo
Start date: March 8, 2018
Phase: N/A
Study type: Interventional

This trial will compare two strategies for patients with Heart Failure, Left Ventricular systolic dysfunction, and intermediate QRS durations. The control group is conventional CRT. The experimental group is LVendo CRT

NCT ID: NCT02751853 Terminated - Heart Failure Clinical Trials

Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation

ANREP-EF
Start date: December 2016
Phase: N/A
Study type: Interventional

Aim of the study is to assess the effects of abruptly increased afterload on left ventricular contractility and relaxation in patients with heart failure with preserved ejection fraction (HFPEF), patients with heart failure with reduced ejection fraction (HFREF), and patients without HFPEF or HFREF.

NCT ID: NCT02708407 Terminated - Heart Failure Clinical Trials

PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease

PD-HF
Start date: January 2016
Phase: N/A
Study type: Interventional

This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.

NCT ID: NCT02698241 Terminated - Heart Failure Clinical Trials

Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

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

The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device diagnostics that have an implanted commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).

NCT ID: NCT02693002 Terminated - Menopause Clinical Trials

Estrogen Diastolic Heart Failure

Start date: February 2016
Phase: Phase 4
Study type: Interventional

Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).

NCT ID: NCT02689635 Terminated - Heart Failure Clinical Trials

Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure

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

Patients over 18 years of age, admitted to the hospital with HF exacerbation, will be eligible for randomization to low salt or regular diet. Laboratory tests are routinely obtained on admission and on the day (or the day before) of discharge (comprehensive metabolic panel and NT-proBNP) and will be recorded for the study. Daily weights are routinely recorded, and intake/output will be monitored. At discharge, a Diet Acceptability Questionnaire will be performed. After the discharge, participants will return for follow-up visits as needed for clinical indications. Our study coordinator will document changes of symptoms, changes in therapies, and capture clinical events like unscheduled hospital visits or visits to the Emergency Room. Once during the study patients will be asked about their specific food consumption on a prior day, and the Sodium content will be estimated. The final visit will occur in a year (approximately 11-13 months after enrollment). Weight, other vital signs, CMP, BNP, and Diet Acceptability Questionnaire quality of life questionnaire will be collected at this point, if clinically indicated. The majority of study information will be collected from routine care for standard clinical indications. The only components added for study purpose are Diet Acceptability Questionnaire and collection of the information on consumed foods.

NCT ID: NCT02686749 Terminated - Atrial Fibrillation Clinical Trials

Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

CATCH-AF
Start date: June 2016
Phase: Phase 4
Study type: Interventional

This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular (LV) function who have been diagnosed with symptomatic AF within the past 12 months.