This trial is active, not recruiting.

Conditions vasculopathy, allograft
Treatment dobutamine stress echocardiography, coronarography, brachial arterial echography
Sponsor University Hospital, Strasbourg, France
Start date September 2006
End date November 2017
Trial size 120 participants
Trial identifier NCT00384540, 3660


Primary purpose :To early detect cardiac allograft vasculopathy and to identify patients with high risk of cardiac events, by coupling the analysis of the kinetics of the brain natriuretic peptide ( BNP) with that of the left ventricle (LV) during a dobutamine stress echocardiography.

Hypothesis : Plasma BNP elevation and abnormalities of LV kinetic during the ESD, will be associated with the presence of allograft vasculopathy and the arisen of cardiovascular events.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose diagnostic

Primary Outcomes

Cardiovascular events vs Dobutamine stress echocardiography each 2 years
time frame: 5 years

Secondary Outcomes

Flow mediated humeral dilatation each 2 years
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Heart transplant recipients Exclusion criteria: - No respect of inclusion criteria - Pregnancy - Severe renal failure (creatinin clearance < or equal to 30 ml/min) - Dobutamine stress echocardiography contraindication

Additional Information

Official title Allograft Vasculopathy After Heart Transplantation : Diagnostic Interest of Dobutamine Stress Echocardiography and Brain Natriuretic Peptide Coupling
Principal investigator Samy TALHA, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Hospital, Strasbourg, France.