View clinical trials related to Cardiomyopathies.
Filter by:The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and Drug Administration under a Humanitarian Device Exception (HDE).
This is a multi-center, prospective evaluation of left ventricular recovery on conventional therapy in patients with the recent onset of dilated cardiomyopathy. In some subjects with this disorder, the heart will recover significantly over the first year, while others will be left with a chronically weak heart. The proteins that help the heart recover are encoded by genes, which can differ markedly between individuals. The goal of the current study is to determine whether variation in these genes involved affect the probability that the heart will recover. We will also look at which genes are involved in inflammation and which ones are "turned on" (producing proteins) in circulating white blood cells.{These statements will only be added if the site has chosen to participate in RNA analysis}. In addition, this study will look at how levels of proteins in the blood, proteins called "cytokines' which control inflammation and proteins called "neurohormones" which are released when the heart weakens, affect the likelihood of recovery. Enrollment will take place at 15 centers. The goal is to enroll approximately 500 adult subjects (age 18 years or older, both men and women) over the course of approximately 48 months.
We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart pump function due to causes other than heart attack). We will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart muscle).
The study is testing the hypothesis, that the application of low dose erythropoetin beta (35 I.E./kg BW/week) for 6 months following successful coronary revascularization by PCI improves left ventricular remodeling as assessed by cardiac MRI.
The purpose of this study is to determine if an 8hr infusion of nesiritide in the emergency department in the Acutely decompensated heart failure patients will decrease 30 day recidivism.
The purpose of this study is to investigate the effects of immunoadsorption and subsequent IgG substitution in patients with dilated cardiomyopathy compared to a control group.
The following objectives were used for comparison: 1) primary objective: reintubation rate during hospitalization; 2) secondary objectives: length of hospitalization at the Coronary Care Unit; time from intubation to start of weaning; time from start of weaning to extubation; time from SBT and extubation; presence of respiratory infection in patients requiring reintubation; mortality of patients requiring reintubation.
Different studies have shown that fibrosis of the heart increases the risk for a sudden death from e.g. arrhythmias. Magnetic Resonance Imaging (CMR) can easily identify even small areas of fibrosis in the heart muscle after contrast agent application (Gadolinium). With the development of faster scanners and new contrast agents, the detection of small fibrotic areas may even be improved. In this study, we will apply dedicated T1- and T2-weighted CMR sequences before and after administration of Gadolinium-based contrast (Gadobutrol, Gadovist(r)), the study parameters will be full cardiac function, areas of edema, areas of inflammation and areas of fibrosis. We hypothesize, that we can detect fibrotic areas in the myocardium using Gadobutrol (Gadovist (r)) better than with the commonly used Gadolinium-DTPA contrast agents. We also hypothesize, that fibrosis of the myocardium is correlated to prognosis of the patients.
The primary objective of this study is to determine the efficacy of ICD therapy compared with control on the endpoint of death from any cause in patients with heart failure of non-ischemic oetiology.
Primary objective: The primary objective of this study is to determine the efficacy of ICD therapy compared with control on the endpoint of death from any cause. Secondary objective: The secondary objectives of the study are to determine if ICD therapy reduces sudden death. Study design: Randomized, unblinded, controlled, parallel two group trial. Primary endpoint: Time to death from any cause. Sample size: In total, 1000 patients with 500 receiving ICD and 500 patients constituting the control group. Summary of Subject Eligibility Criteria: Patients with clinical heart failure, left ventricular ejection fraction (LVEF) ≤ 35%, non-ischemic etiology and NT-proBNP above 200 pg/ml. Patients in NYHA class IV will only be randomised if also fulfilling criteria for a biventricular pacemaker. Control group: Patients receiving standard therapy for heart failure including ACE-inhibitor/Angiotensin-Receptor-Blocker and Betablocker unless not tolerated. Aldosterone antagonism is optional. Study Duration: The study comprises a screening period of up to 2 years, followed by a treatment phase of a minimum of 36 months. Randomisation: After fulfilling all eligibility criteria, subjects will be randomized 1:1 to receive ICD implantation or continue usual control. Randomisation will be stratified according to treatment with a biventricular pacemaker. Treatment: After randomisation patients allocated to ICD treatment should receive this as fast as possible and preferably within 2 weeks (latest 4 weeks). The ICD will be programmed with anti-tachycardia pacing and shock therapy. Assessments: Deaths and hospitalisations for heart failure, stroke or arrhythmias will be recorded throughout the study duration. Statistical Considerations: Median lifetime in the control group is expected to be 5 years. A p-value of 5% (2-sided) is required for significance together with a power of at least 80%. With a relative risk reduction of 25% a sample size of 812 patients in total is required. In order to allow for cross-over a sample size of 1000 is planned. Primary Endpoint Analysis: The principal analysis for the primary endpoint (time to death from any cause) will employ the intent-to-treat principle and use a survival analysis. Secondary Endpoint Analysis: All time-to-event secondary endpoints will be analyzed similarly to the primary endpoint.