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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00402376
• Other study ID #: 3212
• Status: Terminated
• Phase: Phase 4
• First received: November 20, 2006
• Last updated: August 29, 2011
• Start date: April 2007

Study information

• Verified date: August 2011
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Pravastatin, Carvedilol, Perindopril

Device:
• Biventricular assist device (Thoratec paracorporeal assist device)

Locations

Country	Name	City	State
France	Service de Chirurgie Cardiovasculaire - Hôpital Civil	Strasbourg
France	Service de Physiologie Clinique - Hôpital Civil	Strasbourg

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	Institut de Physiologie, Strasbourg, France, Institut National de la Santé Et de la Recherche Médicale, France, Service de Chirurgie Cardiaque

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitochondrial function		at implantation and explantation of VAD
Secondary	Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-a
Secondary	Exercise testing : stress echocardiography, peak oxygen consumption
Secondary	Hormonal cardiac function: ANP, BNP
Secondary	Ventricular remodelling: echocardiography
Secondary	All those parameters will be measured in the post-operative course and every 4 weeks during all the VAD support period.