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| Sponsor: | University Hospital, Strasbourg, France |
|---|---|
| Collaborators: |
Service de Chirurgie Cardiaque Institut de Physiologie, Strasbourg, France Institut National de la Santé Et de la Recherche Médicale, France |
| Information provided by: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT00402376 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: Pravastatin, Carvedilol, Perindopril Device: Biventricular assist device (Thoratec paracorporeal assist device) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure |
| Estimated Enrollment: | 20 |
| 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michel Kindo, MD | 33.3.88.11.59.72 | michel.kindo@chru-strasbourg.fr |
| France | |
| Service de Chirurgie Cardiovasculaire - Hôpital Civil | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Michel Kindo, MD 33.3.88.11.59.72 michel.kindo@chru-strasbourg.fr | |
| Principal Investigator: Michel Kindo, MD | |
| Sub-Investigator: Jean-Philippe Mazzucotelli, MD | |
| Sub-Investigator: Eric Epailly, MD | |
| Service de Physiologie Clinique - Hôpital Civil | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Bernard Geny, MD 33.3.88.11.65.60 bernard.geny@physio-ulp.u-strasbg.fr | |
| Principal Investigator: Bernard Geny, MD | |
| Sub-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 | |
| Study Director: | Bernard Geny, MD | Hôpitaux Universitaires de Strasbourg |
More Information
| Study ID Numbers: | 3212 |
| Study First Received: | November 20, 2006 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00402376 History of Changes |
| Health Authority: | France: Ministry of Health |
|
End-stage heart failure heart failure; ventricular assist device; statin; |
heart transplantation; myocardial function; mitochondrial respiratory function; |
|
Antimetabolites Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Pravastatin Therapeutic Uses Adrenergic beta-Antagonists Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Carvedilol Perindopril |
Heart Failure Heart Diseases Antilipemic Agents Enzyme Inhibitors Cardiovascular Agents Adrenergic alpha-Antagonists Anticholesteremic Agents Antihypertensive Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Protease Inhibitors Adrenergic Antagonists |