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

Tracking Information

First Received Date ^ICMJE

November 20, 2006

Last Updated Date

January 9, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Mitochondrial function [ Time Frame: at implantation and explantation of VAD ]

Original Primary Outcome Measures ^ICMJE

Mitochondrial function: at implantation and explantation of VAD

Change History

Complete list of historical versions of study NCT00402376 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Single Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Michel Kindo, MD

33.3.88.11.59.72

michel.kindo@chru-strasbourg.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00402376

Responsible Party

Study ID Numbers ^ICMJE

3212

Study Sponsor ^ICMJE

University Hospital, Strasbourg, France

Collaborators ^ICMJE

Service de Chirurgie Cardiaque
Institut de Physiologie, Strasbourg, France
Institut National de la Santé Et de la Recherche Médicale, France

Investigators ^ICMJE

Study Director:

Bernard Geny, MD

Hôpitaux Universitaires de Strasbourg

Information Provided By

University Hospital, Strasbourg, France

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP