Cardiac Allograft Vasculopathy and Dobutamine Stress Echocardiography / Brain Natriuretic Peptide Coupling

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France Identifier:
First received: October 5, 2006
Last updated: April 20, 2015
Last verified: April 2015

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.

Condition Intervention
Procedure: Dobutamine stress echocardiography, coronarography, brachial arterial echography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Allograft Vasculopathy After Heart Transplantation : Diagnostic Interest of Dobutamine Stress Echocardiography and Brain Natriuretic Peptide Coupling

Resource links provided by NLM:

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Cardiovascular events vs Dobutamine stress echocardiography each 2 years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Flow mediated humeral dilatation each 2 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2006
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Dobutamine stress echocardiography, coronarography, brachial arterial echography
    DSE: cumulative doses of dobutamine (max = 40 µg/kg/min) and atropine (max = 1.5 mg), to reach a maximal heart rate under clinical, electrocardiographic and echocardiographic surveillancesCoronarography: invasive injection into coronary arteries of a radiological product showing a contrast visible on an x-ray. FMD: Flow-mediated dilatation of the brachial artery induced by 5-min forearm arterial occlusion

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00384540

Service de Physiologie et d'Explorations Fonctionnelles, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Samy TALHA, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00384540     History of Changes
Other Study ID Numbers: 3660 
Study First Received: October 5, 2006
Last Updated: April 20, 2015
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
-Heart Transplant, Allograft Vasculopathy, Dobutamine Stress Echocardiography, Brain Natriuretic Peptide

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Autonomic Agents
Cardiotonic Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Sympathomimetics processed this record on May 26, 2016