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

July 6, 2018 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Physiologie et d'Explorations Fonctionnelles, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cardiovascular events vs Dobutamine stress echocardiography
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular events vs Dobutamine stress echocardiography each 2 years
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Flow mediated humeral dilatation each 2 years
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2006

Primary Completion (Actual)

November 22, 2015

Study Completion (Actual)

December 20, 2016

Study Registration Dates

First Submitted

October 5, 2006

First Submitted That Met QC Criteria

October 5, 2006

First Posted (Estimate)

October 6, 2006

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3660

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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