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Cardiomyopathy, Dilated clinical trials

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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.

NCT ID: NCT00709163 Completed - Clinical trials for Dilated Cardiomyopathy

Nesiritide - Dilated Cardiomyopathy

Start date: December 2003
Phase: N/A
Study type: Interventional

Nesiritide is a rapid vasodilator that mimics the action of an endogenous hormone - human B-type natriuretic peptide (BNP). BNP is produced naturally in the ventricles of the heart in response to stretch. Nesiritide decreases systemic vascular resistance (SVR), pulmonary capillary wedge pressure (PCWP), right atrial pressure (RAP), and mean pulmonary arterial pressure. Nesiritide does not affect the heart rate, but does increase the stroke volume and consequently cardiac output, resulting in a decrease in the symptoms of decompensated heart failure. It is generally well tolerated, with the major negative side effect being hypotension. When compared to standard therapy consisting of dobutamine and nitroglycerin, nesiritide had similar vasodilatory effects, but showed a lower incidence of arrhythmia. Nesiritide has been approved for IV treatment of patients with acutely decompensated congestive heart failure. Although studies have tested the effectiveness and safety of nesiritide in adult CHF patients, this has not been done in children. Subjects enrolled in this study will be pediatric (<21 years) patients carrying a diagnosis of dilated cardiomyopathy with decompensated congestive heart failure. The standard of care for these patients is to undergo cardiac catheterization with placement of a Swan-Ganz catheter for hemodynamic monitoring. Subjects will be randomly assigned to receive either Nesiritide or placebo (5% Dextrose). The infusion will then be continued for a total of twenty-four hours. During this one day period, measurements of systemic blood pressure, central venous pressure (right atrial pressure), pulmonary capillary wedge pressure, cardiac output, mixed venous saturation, pulmonary vascular resistance, and systemic vascular resistance will be measured at regularly scheduled intervals. The Swan-Ganz catheter will remain in place for 2 hours after the discontinuation of study drug, and then removed. The objectives of this study are: 1. To assess the efficacy of Nesiritide therapy in decreasing the pulmonary capillary wedge pressure, right atrial pressure, and systemic vascular resistance in children with dilated cardiomyopathy. 2. To assess the efficacy of Nesiritide in decreasing pulmonary edema and increasing cardiac index in the above mentioned population. 3. To assess the safety of both bolus administration and continuous infusion of Nesiritide in children with dilated cardiomyopathy. 4. To assess the pharmacokinetics of Nesiritide in this population.

NCT ID: NCT00703443 Withdrawn - Clinical trials for Hypertrophic Cardiomyopathy

The Genetics of Cardiomyopathy and Heart Failure

Start date: April 2007
Phase:
Study type: Observational

The purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure.

NCT ID: NCT00646243 Not yet recruiting - Clinical trials for Ischemic Heart Disease

Echo Assessment of Intraventricular Dyssynchrony

IMPROVE
Start date: March 2008
Phase: N/A
Study type: Observational

Background. Clinical benefits of cardiac resynchronization therapy (CRT) have been clearly demonstrated in heart failure (HF) patients with severe left ventricular (LV) dysfunction and wide QRS at surface electrocardiogram. However, there is a growing evidence that QRS duration poorly predicts responses to CRT, and that ~30% of patients do not experience any benefit from CRT when pre-implant dyssynchrony is defined according to electrocardiographic criteria. A number of echocardiographic criteria have been proposed to assess mechanical LV dyssynchrony, but at present there is no consensus on their use to predict response to CRT. Study Design. The Italian Multicenter PROject on echo assessment of left VEntricular (IMPROVE) dyssynchrony study is a prospective, multicenter, observational study aimed to assess feasibility and predictive power of mechanical dyssynchrony assessed by echocardiography in consecutive consenting patients candidate to CRT by clinical and electrocardiographic criteria. IMPROVE will enroll 120 healthy subjects and 216 HF patients in 6 sites in Italy. CRT response criteria will be based on improvement in NYHA class and LV reverse remodeling evaluated by 3D-echocardiography. Enrollment is expected to conclude early 2009. Implications. CRT is today part of the therapeutic armamentarium for symptomatic HF patients refractory to medical therapy, with wide QRS complex and severe LV systolic dysfunction. The IMPROVE study has been designed to evaluate reference values of indexes of ultrasound mechanical dyssynchrony that have been proposed in the literature and compare their ability to predict response to CRT in HF patients.

NCT ID: NCT00629096 Completed - Clinical trials for Dilated Cardiomyopathy

Intracoronary Infusion of Autologous Bone Marrow Cells for Treatment of Idiopathic Dilated Cardiomyopathy

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

The main aim of the study is to determine whether intracoronary infusion of autologous bone marrow mononuclear cells can improve the ventricular function of patients with idiopathic dilated cardiomyopathy.Secondary end-points will be: 1. To evaluate possible changes in patient functional capacity and 2. to identify the biological characteristics of the bone marrow graft that might influence on functional recovery.

NCT ID: NCT00629018 Completed - Clinical trials for Dilated Cardiomyopathy

Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy

Start date: May 2006
Phase: Phase 2
Study type: Interventional

Several studies have documented that transplantation of bone marrow-derived cells (BMC) following acute myocardial infarction is associated with a reduction in infarct scar size and improvements in left ventricular function and perfusion. The available evidence in humans suggests that BMC transplantation is associated with improvements in physiologic and anatomic parameters in both acute myocardial infarction and chronic ischemic heart disease, above and beyond the conventional therapy. In particular, intracoronary application of BMC is proved to be safe and was associated with significant improvement in the left ventricular ejection fraction (LVEF) in patients with chronic heart failure. In contrast to ischemic heart failure, the data on effects of BMC transplantation in patients with dilated cardiomyopathy are limited to pre-clinical studies. In a rat model of dilated cardiomyopathy, intramyocardial delivery of pluripotent mesenchymal cells improved LVEF, possibly through induction of myogenesis and angiogenesis, as well as by inhibition of myocardial fibrosis, suggesting that the beneficial effects of stem cell transplantation in dilated cardiomyopathy may primarily be related to their ability to supply large amounts of angiogenic, antiapoptotic, and mitogenic factors. Similarly, transplantation of cocultured mesenchymal stem cells and skeletal myoblasts was shown to improve LVEF in a murine model of Chagas disease. Study Aim: To define the clinical effects of BMC transplantation in dilated cardiomyopathy in a pilot clinical study investigating the effects of intracoronary CD34+ cell transplantation on functional, structural, neurohormonal, and electrophysiologic parameters in patients with end-stage dilated cardiomyopathy.

NCT ID: NCT00624520 Terminated - Stress Clinical Trials

Mental Stress Reduction in Defibrillator Patients

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

The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators

NCT ID: NCT00622102 Completed - Atrial Fibrillation Clinical Trials

Testing Strategies to Improving Warfarin Adherence

Start date: December 2007
Phase: N/A
Study type: Interventional

We are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin. Individuals from an anticoagulation clinic are being asked to participate in order to see if a lottery which provides the opportunity to win money in combination with the use of the Med-eMonitor might be useful in helping patients to achieve better control of their anticoagulation therapy. Half of the participants will be enrolled in the lottery arm and the other half will be a control group who will receive the Med-eMonitor only.

NCT ID: NCT00615394 Completed - Clinical trials for Dilated Cardiomyopathy

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy

STEMDILCARD
Start date: April 2004
Phase: Phase 1/Phase 2
Study type: Interventional

Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.