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

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

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Pravastatin, Carvedilol, Perindopril
* Device: Biventricular assist device (Thoratec paracorporeal assist device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pravastatin, Carvedilol, Perindopril|nan|
|Device: Biventricular assist device (Thoratec paracorporeal assist device)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitochondrial function |  | at implantation and explantation of VAD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-stage heart failure, heart failure;, ventricular assist device;, statin;, heart transplantation;, myocardial function;, mitochondrial respiratory function;