Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
- Conditions
- Heart Failure
- Registration Number
- NCT00402376
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
- 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
- Myocarditis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mitochondrial function at implantation and explantation of VAD
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (2)
Service de Physiologie Clinique - Hôpital Civil
🇫🇷Strasbourg, France
Service de Chirurgie Cardiovasculaire - Hôpital Civil
🇫🇷Strasbourg, France