VasculopathyNCT00384540
Cardiac Allograft Vasculopathy and Dobutamine Stress Echocardiography / Brain Natriuretic Peptide Coupling
A study testing Dobutamine stress echocardiography, coronarography, brachial arterial echography in people with Vasculopathy and Allograft, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasculopathy, Allograft
- What is being tested?
- Dobutamine stress echocardiography, coronarography, brachial arterial echography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to 20 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart transplant recipients
Who cannot join
- No respect of inclusion criteria
- Pregnancy
- Severe renal failure (creatinin clearance < or equal to 30 ml/min)
- Dobutamine stress echocardiography contraindication
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Physiologie et d'Explorations Fonctionnelles, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: 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.
- Conditions
- Vasculopathy, Allograft
- Being tested
- Dobutamine stress echocardiography, coronarography, brachial arterial echography
- Keywords
- -Heart Transplant, Allograft Vasculopathy, Dobutamine Stress Echocardiography, Brain Natriuretic Peptide, Vasculopathy
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine stress echocardiography, coronarography, brachial arterial echographyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular events vs Dobutamine stress echocardiography | Other | Not described Receives: Procedure: Dobutamine stress echocardiography, coronarography, brachial arterial echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events vs Dobutamine stress echocardiography each 2 years
Measured: 5 years
Secondary outcomes (1)
Flow mediated humeral dilatation each 2 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startSep 2006
- Primary completion22 Nov 2015
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasculopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samy TALHA, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384540
- Sponsor's protocol ID
- 3660
- Status last verified
- Aug 2017
- First submitted
- 5 Oct 2006
- Last updated
- 10 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allograft Vasculopathy After Heart Transplantation : Diagnostic Interest of Dobutamine Stress Echocardiography and Brain Natriuretic Peptide Coupling
- ClinicalTrials.gov ID
- NCT00384540
- Acronym / sponsor ID
- 3660
- Conditions
- Vasculopathy, Allograft
- Keywords
- -Heart Transplant, Allograft Vasculopathy, Dobutamine Stress Echocardiography, Brain Natriuretic Peptide, Vasculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2006 (actual)
- Primary completion
- 22 Nov 2015 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular events vs Dobutamine stress echocardiography | Other | Procedure: Dobutamine stress echocardiography, coronarography, brachial arterial echography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heart transplant recipients
Key exclusion criteria (4 listed)
- No respect of inclusion criteria
- Pregnancy
- Severe renal failure (creatinin clearance < or equal to 30 ml/min)
- Dobutamine stress echocardiography contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dobutamine stress echocardiography, coronarography, brachial arterial echographyDSE: 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 | Procedure or surgery | Cardiovascular events vs Dobutamine stress echocardiography |
Primary outcome
Cardiovascular events vs Dobutamine stress echocardiography each 2 years
Time frame: 5 years
1 secondary outcome
Flow mediated humeral dilatation each 2 years
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samy TALHA, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dobutamine stress echocardiography, coronarography, brachial arterial echography in people with Vasculopathy and Allograft, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events vs Dobutamine stress echocardiography each 2 years (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.