View clinical trials related to Cardiomyopathy, Dilated.
Filter by:The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.
BACKGROUND. In patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell transplantation has been shown to improve exercise capacity, reduce ventricular remodelling and improve 1-year survival. Pre-clinical data demonstrate that stem cell effects on the diseased heart can be further enhanced by direct intramyocardial delivery route. AIMS. 1. To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with non-ischemic dilated cardiomyopathy. 2. To directly compare clinical effects of intracoronary and intramyocardial stem cell delivery. METHODS. Of 60 patients with dilated cardiomyopathy, 30 will be randomized to intramyocardial transplantation of CD34+ cells (Study Group), and 30 will receive intracoronary stem cell therapy (Control Group). In both groups peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. In the Study Group electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter. In the Control group patients will undergo myocardial perfusion scintigraphy and CD34+ cells will be injected intracoronary in the artery supplying segments of reduced viability. Patients will be followed for 1 year. Primary endpoints will include changes in left ventricular ejection fraction and left ventricular dimensions (measured by echocardiography). Secondary endpoints will include changes in exercise capacity and changes in NT-proBNP values. HYPOTHESES. 1. At 1 year, intramyocardial stem cell therapy will be associated with improved left ventricular ejection fraction, reduced left ventricular dimensions, improved exercise capacity and reduced levels of NT-proBNP. 2. Beneficial effects of intramyocardial stem cell therapy will be superior to those observed with intracoronary stem cell delivery.
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Algisyl-LVR™ will be injected into the myocardium under direct visualization during the surgical procedure. This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV size, restore LV shape, lower LV wall stress and improve global LV function. The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake) from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device The hypothesis of the study is that there is a statistically significant difference in change in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is compared to the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.
A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary injection of progenitor cells compared to placebo injection in patients with Dilated Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo injection
The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin capsule, a Chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in patients with DCM, patients were recruited, anti-heart autoantibodies and some representative cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of heart function improvement was compared between Qiliqiangxin capsule and placebo under the standard treatment of DCM.
Impact of intraventricular electrical activation in resynchronization therapy. We seek to evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to decrease the heterogeneity of LV activation in heart failure patients. A second goal is to evaluate the electrical determinant of clinical response to CRT using invasive and non-invasive mapping technology.
Biventricular pacing is a validated treatment for patients suffering from heart failure resistant to medical treatment. However, up to 30% of the patients are non responsive to this strategy using the coronary sinus approach to pace the Left Ventricle (LV). It has been demonstrated that the magnitude of the improvement was highly dependant on the LV pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing sites. Resynchronisation using a transeptal approach to pace the left ventricle on the cardiology has been shown feasible on small series. We therefore would like to compare these two approached in a randomised prospective study to confirm the hypotheses that endocardial LV pacing by offering multiple choices for the pacing sites reduces the number of non responders and is associated with greater hemodynamic benefit when compared to the conventional coronary sinus approach.
The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular systolic function in patients with stable chronic HF secondary to nonischemic dilated cardiomyopathy (NICM).
The aim of the present study is to compare the response to cardiac resynchronization therapy (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF) depending on atrio ventricular junction (AVJ) is ablated or not.
This study is designed to assess the safety profile and the efficacy of cardiac repair cells (CRCs) administered via catheter in treating patients with dilated cardiomyopathy (DCM).