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Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, January 2009
First Received: November 20, 2006   Last Updated: January 9, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Mitochondrial function [ Time Frame: at implantation and explantation of VAD ]

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: April 2007
Detailed Description:

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402376

Contacts
Contact: Michel Kindo, MD 33.3.88.11.59.72 michel.kindo@chru-strasbourg.fr

Locations
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            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Service de Chirurgie Cardiaque
Institut de Physiologie, Strasbourg, France
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Bernard Geny, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

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

Keywords provided by University Hospital, Strasbourg, France:
End-stage heart failure
heart failure;
ventricular assist device;
statin;
heart transplantation;
myocardial function;
mitochondrial respiratory function;

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010