Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy

Condition(s) targeted: Heart Failure

Intervention: Pravastatin, Carvedilol, Perindopril (Drug); Biventricular assist device (Thoratec paracorporeal assist device) (Device)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Strasbourg, France

Official(s) and/or principal investigator(s):
Bernard Geny, MD, Study Director, Affiliation: Hôpitaux Universitaires de Strasbourg

Overall contact:
Michel Kindo, MD, Phone: 33.3.88.11.59.72, Email: michel.kindo@chru-strasbourg.fr

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.

Official title: Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Mitochondrial function

Secondary outcome:

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.

Detailed description: Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with end-stage heart failure refractory to medical therapy and who fulfill

criteria for VAD implantation as a bridge to heart transplantation

- Age > 18

Exclusion Criteria:

- Myocarditis

Michel Kindo, MD, Phone: 33.3.88.11.59.72, Email: michel.kindo@chru-strasbourg.fr

Service de Chirurgie Cardiovasculaire - Hôpital Civil, Strasbourg 67091, France; Recruiting
Michel Kindo, MD, Phone: 33.3.88.11.59.72, Email: michel.kindo@chru-strasbourg.fr
Michel Kindo, MD, Principal Investigator
Jean-Philippe Mazzucotelli, MD, Sub-Investigator
Eric Epailly, MD, Sub-Investigator

Service de Physiologie Clinique - Hôpital Civil, Strasbourg 67091, France; Recruiting
Bernard Geny, MD, Phone: 33.3.88.11.65.60, Email: bernard.geny@physio-ulp.u-strasbg.fr
Bernard Geny, MD, Principal Investigator
Stéphane Doutreleau, MD, Sub-Investigator
J. Zoll, MD, Sub-Investigator
Samy Talha, MD, Sub-Investigator
Olivier Rouyer, MD, Sub-Investigator
Analia Paola Di Marco, MD, Sub-Investigator

Starting date: April 2007
Last updated: January 9, 2009