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: February 17, 2014
Last verified: February 2014

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
  Contacts and Locations
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

No publications provided

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00384540     History of Changes
Other Study ID Numbers: 3660
Study First Received: October 5, 2006
Last Updated: February 17, 2014
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:
Natriuretic Peptide, Brain
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Natriuretic Agents processed this record on April 22, 2014