Clinical trial NCT00402376: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Keywords: End-stage heart failure
heart failure;
ventricular assist device;
statin;
heart transplantation;
myocardial function;
mitochondrial respiratory function;
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Service de Chirurgie Cardiaque
name: Institut de Physiologie, Strasbourg, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2006-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Mitochondrial function
timeFrame: at implantation and explantation of VAD
Secondary outcomes:
measure: Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-α
measure: Exercise testing : stress echocardiography, peak oxygen consumption
measure: Hormonal cardiac function: ANP, BNP
measure: Ventricular remodelling: echocardiography
measure: All those parameters will be measured in the post-operative course and every 4 weeks during all the VAD support period.
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Cardiovasculaire - Hôpital Civil
city: Strasbourg
country: France
facility: Service de Physiologie Clinique - Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Bernard Geny, MD
role: STUDY_DIRECTOR
References: