Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
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.
Drug: Pravastatin, Carvedilol, Perindopril
Device: Biventricular assist device (Thoratec paracorporeal assist device)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure|
- Mitochondrial function [ Time Frame: at implantation and explantation of VAD ]
- Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-α
- Exercise testing : stress echocardiography, peak oxygen consumption
- Hormonal cardiac function: ANP, BNP
- Ventricular remodelling: echocardiography
- All those parameters will be measured in the post-operative course and every 4 weeks during all the VAD support period.
|Study Start Date:||April 2007|
Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
|Service de Chirurgie Cardiovasculaire - Hôpital Civil|
|Strasbourg, France, 67091|
|Service de Physiologie Clinique - Hôpital Civil|
|Strasbourg, France, 67091|
|Study Director:||Bernard Geny, MD||Hôpitaux Universitaires de Strasbourg|