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

August 29, 2011 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Chirurgie Cardiovasculaire - Hôpital Civil
      • Strasbourg, France, 67091
        • Service de Physiologie Clinique - Hôpital Civil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mitochondrial function
Time Frame: at implantation and explantation of VAD
at implantation and explantation of VAD

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Collaborators

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

Investigators

  • Study Director: Bernard Geny, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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