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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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00402376
Enrollment
20
Registered
2006-11-22
Start date
2007-04-30
Completion date
Unknown
Last updated
2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

End-stage heart failure, heart failure;, ventricular assist device;, statin;, heart transplantation;, myocardial function;, mitochondrial respiratory function;

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

Interventions

DRUGPravastatin, Carvedilol, Perindopril
DEVICEBiventricular assist device (Thoratec paracorporeal assist device)

Sponsors

Service de Chirurgie Cardiaque
CollaboratorUNKNOWN
Institut de Physiologie, Strasbourg, France
CollaboratorUNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mitochondrial functionat implantation and explantation of VAD

Secondary

MeasureTime 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026