Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedAugust 30, 2011
August 1, 2011
November 20, 2006
August 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mitochondrial function
at implantation and explantation of VAD
Secondary Outcomes (5)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Myocarditis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service de Chirurgie Cardiovasculaire - Hôpital Civil
Strasbourg, 67091, France
Service de Physiologie Clinique - Hôpital Civil
Strasbourg, 67091, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bernard Geny, MD
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 20, 2006
First Posted
November 22, 2006
Study Start
April 1, 2007
Last Updated
August 30, 2011
Record last verified: 2011-08