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Heart Failure clinical trials

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NCT ID: NCT03262571 Terminated - Clinical trials for Chronic Heart Failure

Usefulness of Lung Ultrasound in Ambulatory Management of Patients With Chronic Heart Failure

Start date: December 2010
Phase: Phase 3
Study type: Interventional

Purpose. The aim of this study is to evaluate whether lung ultrasound, in addition to physical examination, leads to a reduction of the admission rate for acute decompensated heart failure of patients with chronic heart failure (HF) followed in the outpatients heart failure clinic. Methods. This is a prospective randomized study. The planned sample size consists of 440 patients with chronic HF. The inclusion criteria are: (1) male and female aged between 18 and 90 years (2) signed written informed consent (3) history of HF for at least six months, (4) left ventricular ejection fraction < 45%, (5) adequate medical therapy for HF for at least two months. The exclusion criteria are: (1) concomitant enrollment in other clinical studies, or treatment with experimental drugs or devices within 30 days of clinical assessment, (2) inability to undergo to the planned follow-up and procedures (3) documented pulmonary infections (3) interstitial lung disease and class 4 chronic obstructive pulmonary disease according to GOLD classification. Patients are randomized in two groups: group A, patients undergoing to lung ultrasound and physical examination; and group B, patients undergoing to physical examination only. Patients are evaluated at baseline and after three months with medical history, Quality of Life test, physical examination, blood sample for hematochemical (creatinine, electrolytes, BNP/NTpro-BNP). The diuretic therapy is then optimized according to the presence and severity of B-lines in group A and physical examination in group B. Only patients enrolled in group A undergo to a lung ultrasound examination to assess the extent of pulmonary congestion, through its evidence of B-lines. B-lines originate from the contrast between air-filled structures and water-thickened pulmonary interlobular septa. This leads to linear echogenic vertical artefacts that spread from the pleural layers downwards in the screen. The ultrasound examination is performed with a handheld echocardiography device. The physician carries out a scan of the pulmonary fields, from basal towards mid and apical fields, through the midaxillary line while the patient lies supine. The quantification of B-lines is performed according to their extent over the lung fields. All the information are recorded in dedicated forms. The results are evaluated according to the following criteria. The primary end-point is a significant reduction of hospitalizations for acute decompensated HF in group A during the follow-up period. The secondary end-points are changes of NT-proBNP values, quality of life test (QLT) score and cardiac mortality.

NCT ID: NCT03258060 Terminated - Heart Failure Clinical Trials

CRT In Narrow QRS Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping

Start date: April 2014
Phase: N/A
Study type: Interventional

Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see if cardiac MRI can be used to select patients with normal electrical conduction for CRT, therefore expanding the number of people who would stand to benefit from this treatment.

NCT ID: NCT02859636 Terminated - Cardiac Failure Clinical Trials

Pronostic Value of Endothelial Dysfunction in Heart Failure

Pro-ICARD
Start date: October 2012
Phase: N/A
Study type: Observational

The main objective is to evaluate the pronostic value of endothelial dysfonction in acute heart failure on a combined criteria associating cardiovascular mortality, nex hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2 month and 1 year before acute heart failure.

NCT ID: NCT02857309 Terminated - Heart Failure Clinical Trials

Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure

IMPULSE-HF
Start date: February 2014
Phase: N/A
Study type: Interventional

The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM) in the heart failure population with ejection fraction ranging between 25 and 45%. The study is designed in an adaptive manner to ensure proper statistical significance and power of the primary efficacy evaluation.

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: 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: NCT02625922 Terminated - Clinical trials for Chronic Heart Failure

Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure

RELAX-Cardio
Start date: February 5, 2016
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study to evaluate the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

NCT ID: NCT02596477 Terminated - Clinical trials for Chronic Heart Failure

Evaluation of Vepoloxamer in Chronic Heart Failure

Start date: October 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. This will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.

NCT ID: NCT02543632 Terminated - Heart Failure Clinical Trials

PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE.

P5
Start date: August 2015
Phase: N/A
Study type: Observational [Patient Registry]

Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.

NCT ID: NCT02505867 Terminated - Heart Failure Clinical Trials

The Role of Sleep Disordered Breathing in Heart Failure Admissions

Start date: November 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of in-hospital diagnosis and treatment of sleep disordered breathing (SDB) on post-discharge mortality and readmissions in- hospitalized patients with acute heart failure syndrome and reduced ejection fraction (HFrEF).