search
Back to results

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

Primary Purpose

Vasculopathy, Allograft

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dobutamine stress echocardiography, coronarography, brachial arterial echography
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vasculopathy focused on measuring -Heart Transplant, Allograft Vasculopathy, Dobutamine Stress Echocardiography, Brain Natriuretic Peptide, Vasculopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cardiovascular events vs Dobutamine stress echocardiography

Arm Description

Outcomes

Primary Outcome Measures

Cardiovascular events vs Dobutamine stress echocardiography each 2 years

Secondary Outcome Measures

Flow mediated humeral dilatation each 2 years

Full Information

First Posted
October 5, 2006
Last Updated
July 6, 2018
Sponsor
University Hospital, Strasbourg, France
search

1. Study Identification

Unique Protocol Identification Number
NCT00384540
Brief Title
Cardiac Allograft Vasculopathy and Dobutamine Stress Echocardiography / Brain Natriuretic Peptide Coupling
Official Title
Allograft Vasculopathy After Heart Transplantation : Diagnostic Interest of Dobutamine Stress Echocardiography and Brain Natriuretic Peptide Coupling
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2006 (Actual)
Primary Completion Date
November 22, 2015 (Actual)
Study Completion Date
December 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculopathy, Allograft
Keywords
-Heart Transplant, Allograft Vasculopathy, Dobutamine Stress Echocardiography, Brain Natriuretic Peptide, Vasculopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiovascular events vs Dobutamine stress echocardiography
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Dobutamine stress echocardiography, coronarography, brachial arterial echography
Intervention Description
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
Primary Outcome Measure Information:
Title
Cardiovascular events vs Dobutamine stress echocardiography each 2 years
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Flow mediated humeral dilatation each 2 years
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samy TALHA, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Physiologie et d'Explorations Fonctionnelles, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs