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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Pravastatin, Carvedilol, Perindopril
Biventricular assist device (Thoratec paracorporeal assist device)
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring End-stage heart failure, heart failure;, ventricular assist device;, statin;, heart transplantation;, myocardial function;, mitochondrial respiratory function;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Chirurgie Cardiovasculaire - Hôpital Civil
  • Service de Physiologie Clinique - Hôpital Civil

Outcomes

Primary Outcome Measures

Mitochondrial function

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.

Full Information

First Posted
November 20, 2006
Last Updated
August 29, 2011
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
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1. Study Identification

Unique Protocol Identification Number
NCT00402376
Brief Title
Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
Official Title
Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
End-stage heart failure, heart failure;, ventricular assist device;, statin;, heart transplantation;, myocardial function;, mitochondrial respiratory function;

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pravastatin, Carvedilol, Perindopril
Intervention Type
Device
Intervention Name(s)
Biventricular assist device (Thoratec paracorporeal assist device)
Primary Outcome Measure Information:
Title
Mitochondrial function
Time Frame
at implantation and explantation of VAD
Secondary Outcome Measure Information:
Title
Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-α
Title
Exercise testing : stress echocardiography, peak oxygen consumption
Title
Hormonal cardiac function: ANP, BNP
Title
Ventricular remodelling: echocardiography
Title
All those parameters will be measured in the post-operative course and every 4 weeks during all the VAD support period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Geny, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Study Director
Facility Information:
Facility Name
Service de Chirurgie Cardiovasculaire - Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Physiologie Clinique - Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

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

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