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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00384540
First received: October 5, 2006
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  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

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:

U.S. FDA Resources

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:
    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
  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

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00384540     History of Changes
Other Study ID Numbers: 3660
Study First Received: October 5, 2006
Last Updated: January 11, 2013
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Dobutamine
Natriuretic Peptide, Brain
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
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

ClinicalTrials.gov processed this record on June 17, 2013