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Cardiomyopathies clinical trials

View clinical trials related to Cardiomyopathies.

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NCT ID: NCT00879060 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy

Start date: November 2007
Phase: Phase 4
Study type: Interventional

Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the leading cause of sudden cardiac death in young people and an important cause of heart failure symptoms and death at any age. In HCM, pathological remodeling of the left ventricle involving myocardial fibrosis is likely a major contributor to cardiac dysfunction and also a nidus for the generation of ventricular arrhythmias. Serum markers of collagen turnover have been shown to reliably reflect the magnitude of myocardial fibrosis in a variety of cardiovascular diseases. In addition, aldosterone antagonist drugs have been shown to decrease fibrous tissue formation in the myocardium in certain pathologic cardiovascular states in which aldosterone production is increased. In HCM, aldosterone production is up-regulated and has been implicated in the formation of myocardial fibrosis. Therefore, the specific aims of this proposal are to: 1. assess serum markers of collagen turnover at baseline and correlate these findings with a variety of clinical and morphologic disease parameters 2. examine the effects of a 12-month treatment with the aldosterone antagonist spironolactone on magnitude of fibrosis as measured by serum markers of collagen turnover as well as changes in clinical and morphologic disease parameters. 3. explore the effects of a 12-month treatment with aldosterone antagonist spironolactone on heart failure status, diastolic function, arrhythmic burden, and total LV mass and quantity of fibrosis by CMR. The results of this proposal will offer important insights into the clinical significance of myocardial fibrosis in this primary genetic cardiomyopathy. The demonstration that spironolactone decreases fibrosis and improves clinical course would provide the rational for a larger multicenter clinical trial evaluating this novel therapy for improving clinical outcome in patients with HCM.

NCT ID: NCT00847964 Completed - Clinical trials for Dilated Cardiomyopathy

Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery

Start date: February 2009
Phase: Phase 2
Study type: Interventional

This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular restoration in patients with dilated cardiomyopathy who are scheduled to undergo routine open heart surgery. Algisyl-LVR™ will be injected into the myocardium under direct visualization during the surgical procedure. This clinical evaluation is intended to provide the initial evidence of the safety and feasibility of the device as well as the procedure used to deploy the device. The results of the initial trial will also help to establish the utility of various assessments in evaluating and following the effects of the device.

NCT ID: NCT00824005 Completed - Clinical trials for Ischemic Cardiomyopathy

Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)

Start date: March 2009
Phase: Phase 2
Study type: Interventional

Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses stem cells—specialized cells capable of developing into other types of cells—to stimulate growth of new blood vessels for the heart. This study will determine the safety and effectiveness of withdrawing stem cells from someone's bone marrow and injecting those cells into the person's heart as a way of treating people with CAD and heart failure.

NCT ID: NCT00821353 Completed - Atrial Fibrillation Clinical Trials

Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Start date: January 2009
Phase: Phase 3
Study type: Interventional

Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome. Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients. Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.

NCT ID: NCT00810550 Completed - Clinical trials for Coronary Artery Disease

Carotid Ultrasound in the Evaluation of Heart Failure

CUE-HF
Start date: October 2005
Phase: N/A
Study type: Interventional

Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

NCT ID: NCT00800761 Completed - Cardiomyopathy Clinical Trials

Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major

DFODFPTM
Start date: December 2001
Phase: Phase 4
Study type: Interventional

Myocardial iron overload is the leading cause of death in patients with beta-thalassemia major (TM). Therapy with deferoxamine (DFO) combined with deferiprone (DFP) reduces myocardial iron and improves cardiac function. However, the prognosis for TM patients with established cardiac disease switched from DFO monotherapy to combined DFP/DFO chelation is unknown. Twenty-eight TM patients with cardiac disease were enrolled in a prospective study lasting 42±6 months. Fifteen (9 high-ferritin and 6 low-ferritin) were placed on DFP/DFO (DFP, 75 mg/kg t.i.d.; DFO, 40-50 mg/kg over 8-12 h at night 5-7 d/wk), while 13 (5 high- and 8 low-ferritin) received DFO alone. No cardiac events were observed among high-ferritin patients on combination therapy, whereas 4 cardiac events (p=0.0049), including three deaths, occurred in high-ferritin patients on DFO monotherapy. These findings demonstrate that in TM patients with well-established cardiac disease combined iron-chelation therapy with DFP/DFO is superior to DFO monotherapy.

NCT ID: NCT00765518 Completed - Clinical trials for Dilated Cardiomyopathy

Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)

Start date: September 2008
Phase: Phase 2
Study type: Interventional

This study is designed to assess the safety and tolerability of Cardiac Repair Cells (CRCs) compared to standard-of-care in patients with dilated cardiomyopathy (DCM).

NCT ID: NCT00753233 Completed - Clinical trials for Hypertrophic Cardiomyopathy (HCM)

Identification of Risk Factors for Arrhythmia in Children and Adolescents With Hypertrophic Cardiomyopathy

Start date: September 5, 2008
Phase: N/A
Study type: Observational

This study will review medical information collected on children and adolescents with hypertrophic cardiomyopathy (HCM) to try to identify risk factors for arrhythmias (abnormal heart rhythms) in these patients and better guide the choice of treatment options for them. Arrhythmias arising from the ventricle (lower heart chamber) can cause dizziness, fainting or cardiac arrest. Predictors of arrhythmias in adult HCM patients may not apply to children and teenagers with HCM. Children and adolescents 21 years of age or younger who were diagnosed with HCM and evaluated in the National Heart Lung and Blood Institute's Cardiology Branch between 1977 and 2002 may be eligible for this study. Participants do not undergo any further testing or data gathering beyond a review of their medical records; only existing data previously collected for research purposes are used. Medical records are reviewed for age of the patient on admission to the NIH; family history of sudden death, fainting, exercise-induced low blood pressure, and results of tests on heart structure and function.

NCT ID: NCT00743639 Completed - Clinical trials for Dilated Cardiomyopathy

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy

SDILCM
Start date: July 2005
Phase: Phase 2/Phase 3
Study type: Interventional

This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.

NCT ID: NCT00741156 Completed - Hypertension Clinical Trials

The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution

Start date: July 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to study the acute effects of angiotensin-converting enzyme inhibitor (ACEI) on systemic, pulmonary and cerebral blood flow in post bidirectional cavopulmonary connection (BCPC) patients.