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

Allograft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384540
• Other study ID #: 3660
• Status: Completed
• Phase: N/A
• Start date: September 2006
• Est. completion date: December 20, 2016

Study information

• Verified date: August 2017
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 20, 2016
• Est. primary completion date: November 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allograft
• Vascular Diseases
• Vasculopathy

Intervention

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

Locations

Country	Name	City	State
France	Service de Physiologie et d'Explorations Fonctionnelles, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events vs Dobutamine stress echocardiography each 2 years		5 years
Secondary	Flow mediated humeral dilatation each 2 years		5 years