Cardiac Allograft Vasculopathy and Dobutamine Stress Echocardiography / Brain Natriuretic Peptide Coupling - Full Text View

Purpose

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
Vasculopathy Allograft	Procedure: Dobutamine stress echocardiography, coronarography, brachial arterial echography

MedlinePlus related topics:

Heart Transplantation Stress

Drug Information available for:

Nesiritide Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate Atropine Atropine sulfate X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind (Investigator), Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Allograft Vasculopathy After Heart Transplantation : Diagnostic Interest of Dobutamine Stress Echocardiography and Brain Natriuretic Peptide Coupling

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 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00384540

Contacts


Contact: Bernard GENY, MD	33.3.88.11.50.38

Contact: Samy TALHA, MD	33.3.88.11.64.76	samy.talha@chru-strasbourg.fr

Locations


France
	Service de Physiologie et d'Explorations Fonctionnelles, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Recruiting
	STRASBOURG, France, 67091
	Sub-Investigator: Bernard GENY, MD
	Sub-Investigator: Jean-Marie MOSSARD, MD
	Sub-Investigator: Olivier ROUYER, MD
	Sub-Investigator: Stéphane DOUTRELEAU, MD
	Sub-Investigator: Eric EPAILLY, MD
	Sub-Investigator: Christian BRANDT, MD
	Sub-Investigator: Pierre ATTALI, MD
	Sub-Investigator: Paola DI MARCO, MD
	Sub-Investigator: Hafida SAMET, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators


Principal Investigator:	Samy TALHA, MD	Hôpitaux Universitaires de Strasbourg

More Information

Responsible Party:	University Hospital, Strasbourg, France ( Emmanuel LAVOUE, Directeur Adjoint de la DRCI )
Study ID Numbers:	3660
First Received:	October 5, 2006
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00384540
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:

-Heart Transplant, Allograft Vasculopathy, Dobutamine Stress Echocardiography, Brain Natriuretic Peptide

Vasculopathy

Study placed in the following topic categories:

Natriuretic Peptide, Brain

Stress

Dobutamine

Atropine

Additional relevant MeSH terms:

Neurotransmitter Agents

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Cardiotonic Agents

Sympathomimetics

Physiological Effects of Drugs

Cardiovascular Agents

Protective Agents

Pharmacologic Actions

Adrenergic Agonists

Natriuretic Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00384540