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

This study has been terminated.
Sponsor:
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
First received: November 20, 2006
Last updated: August 29, 2011
Last verified: August 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov Identifier: NCT00402376     History of Changes
Other Study ID Numbers: 3212
Study First Received: November 20, 2006
Last Updated: August 29, 2011
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:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014