Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
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|ClinicalTrials.gov Identifier: NCT00402376|
Recruitment Status : Terminated
First Posted : November 22, 2006
Last Update Posted : August 30, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Pravastatin, Carvedilol, Perindopril Device: Biventricular assist device (Thoratec paracorporeal assist device)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure|
|Study Start Date :||April 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402376
|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|