NCT00384540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2016

Completed
Last Updated

July 10, 2018

Status Verified

August 1, 2017

Enrollment Period

9.2 years

First QC Date

October 5, 2006

Last Update Submit

July 6, 2018

Conditions

VasculopathyAllograft

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular events vs Dobutamine stress echocardiography each 2 years

    5 years

Secondary Outcomes (1)

  • Flow mediated humeral dilatation each 2 years

    5 years

Study Arms (1)

Cardiovascular events vs Dobutamine stress echocardiography

OTHER
Procedure: Dobutamine stress echocardiography, coronarography, brachial arterial echography

Interventions

Dobutamine stress echocardiography, coronarography, brachial arterial echographyPROCEDURE

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

Cardiovascular events vs Dobutamine stress echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart transplant recipients

You may not qualify if:

  • Pregnancy
  • Severe renal failure (creatinin clearance \< or equal to 30 ml/min)
  • Dobutamine stress echocardiography contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Samy TALHA, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 6, 2006

Study Start

September 1, 2006

Primary Completion

November 22, 2015

Study Completion

December 20, 2016

Last Updated

July 10, 2018

Record last verified: 2017-08

Locations

FR(1)