Heart Failure Clinical Trial
Official title:
Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure
Cardiac function may improve in patients with end-stage heart failure who receive long-term
support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be
sufficient in some cases to allow explantation of the VAD. However, some questions continue
to await definitive answers. This study is designed to assess the myocardial recovery under
VAD support with optimal pharmacological therapy (high doses [group I] of statins,
beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses [group II]).
The study is a randomized, single-blind trial performed at the Department of Cardiac
Surgery, University of Strasbourg, France. Twenty patients with end-stage heart failure who
will be supported by VAD (Thoratec paracorporeal device) as a bridge to heart
transplantation will be included. Reverse left ventricular remodeling and myocardial
function will be studied by: echocardiography, respiratory mitochondrial function, exercise
testing, cardiac hormonal function, and inflammatory response. Myocardial biopsies will be
obtained at the time of VAD implantation and heart transplantation. The follow-up will be
performed every 4 weeks during the VAD support period. The hypothesis of this trial is that
reverse left ventricular remodeling and myocardial function will improve under optimal
medical therapy especially by a high dose statin.
Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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