Congenital Heart Disease With Systemic Right VentricleSTARSNCT02066506
Study of Adaptation of the Right Ventricle to Systemic Afterload
A study testing asymptomatic group and symptomatic group in people with Congenital Heart Disease With Systemic Right Ventricle, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
the first purpose of the study is to determine the adaptative mechanisms of right ventricle (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease With Systemic Right Ventricle
- What is being tested?
- asymptomatic group and symptomatic group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Feb 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Patients inclusion criteria:
- patients with a systemic right ventricle
- to have an insurance
- to obtain informed consent
Patients non-inclusion criteria:
- patients with cyanosis defined by a saturation ≤ 85% at rest
- patients with a ventricular septal defect non repaired at the time of inclusion
- contraindications normal MRI
- contraindication to achieving a stress test
- Glomerular Filtration Rate inf 30ml/mn/1.73m²
- physical or mental disability that does not allow to perform a cardiopulmonary exercise test
- patients with already severe allergy to gadolinium MRI contrast
- current Pregnancy
- patients who can not be monitored over the period of one year, patient participating in another research on the Treatment interacting with the neurohormonal system in particular the renin-angiotensin-aldosterone system healthy subjects inclusion criteria:
- matched for age and sex + / - 5 years of an asymptomatic patient
- Normal ECG
- normal Echocardiography
- clinical examination prior
- Patient receiving an insurance
- Obtaining informed consent healthy subjects Exclusion criteria:
- History of myocardial infarction-known or detectable on the ECG-abnormal Liver function tests
- Complete Blood Count
- electrolytes
- viral serology
- Primary or secondary cardiomyopathy-known or detectable on echocardiography
- History of thoracic radiotherapy or chemotherapy
- Contraindications MRI
- Counter-indication for performing a stress test
- Patient with severe renal clearance less than Glomerular Filtration Rate inf 30ml/mn/1.73m²
- Patient has already made a severe allergy to gadolinium MRI contrast Current Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
the first purpose of the study is to determine the adaptative mechanisms of right ventricle (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels
Read the detailed description
Right ventricle (RV) in sub-aortic position is a rare situation, mainly in two congenital heart defects: congenitally corrected transposition of the great arteries and complete transposition of the great arteries palliated by atrial switch. In these patients, increase of afterload leads to hypertrophy and late RV dilatation. The stress exercised on RV walls could play a role in adaptative mechanisms to systemic afterload. Beyond a remodelling threshold, it could cause fibrosis damage and RV systolic failure. Magnetic resonance imaging, which has a major potential in estimation of RV remodelling, wall stress and fibrosis, could shed light on RV adaptation to systemic afterload and evolution towards failure. Systemic RV remodelling and function could also depend on the neuro-hormone secretion and mechanical arterial properties, that have a direct influence on patients afterload. The first purpose of the study is to determine the adaptative mechanisms of RV to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels
- Being tested
- asymptomatic group, symptomatic group
- Keywords
- systemic right ventricle, cardiac magnetic resonance imaging, congenital heart disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asymptomatic groupOther
2 visits with MRI
symptomatic groupOther
2 visits with MRI
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic group | Sham comparator | patients with systemic right ventricle who are asymptomatic, Receives: Other: asymptomatic group |
| symptomatic group | Sham comparator | symptomatic group : patients with systemic right ventricle and heart failure signs and/or decrease exercise performance Receives: Other: symptomatic group |
| control | Sham comparator | healthy subject matched with patients of asymptomatic group Receives: Other: asymptomatic group; Other: symptomatic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
remodelling indexes
Measured: 48 months
wall stress index
Measured: 48 months
fibrosis of systemic RV measured by MRI
Measured: 48 months
Secondary outcomes (4)
echographic measures of RV function and geometry indexes
comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow
Measured: 48 months
Arterial mechanical properties (stiffness aortic distensibility and arterial compliance)
comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow
Measured: 48 months
Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides
Measured: 48 months
Variability and reproducibility indices remodeling and wall stress MRI
inter and intra-observer variability and inter-examination MRI measures
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease With Systemic Right VentricleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magalie Ladouceur, MD, Principal investigator, Université Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066506
- Sponsor's protocol ID
- P080609
- Acronym
- STARS
- Status last verified
- Aug 2012
- First submitted
- 17 Sep 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Adaptation of the Right Ventricle to Systemic Afterload
- ClinicalTrials.gov ID
- NCT02066506
- Acronym / sponsor ID
- STARS / P080609
- Keywords
- systemic right ventricle, cardiac magnetic resonance imaging, congenital heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Feb 2014 (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.
the first purpose of the study is to determine the adaptative mechanisms of right ventricle (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels
Detailed description
Right ventricle (RV) in sub-aortic position is a rare situation, mainly in two congenital heart defects: congenitally corrected transposition of the great arteries and complete transposition of the great arteries palliated by atrial switch. In these patients, increase of afterload leads to hypertrophy and late RV dilatation. The stress exercised on RV walls could play a role in adaptative mechanisms to systemic afterload. Beyond a remodelling threshold, it could cause fibrosis damage and RV systolic failure. Magnetic resonance imaging, which has a major potential in estimation of RV remodelling, wall stress and fibrosis, could shed light on RV adaptation to systemic afterload and evolution towards failure. Systemic RV remodelling and function could also depend on the neuro-hormone secretion and mechanical arterial properties, that have a direct influence on patients afterload. The first purpose of the study is to determine the adaptative mechanisms of RV to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| asymptomatic group | Sham comparator | Other: asymptomatic grouppatients with systemic right ventricle who are asymptomatic, |
| symptomatic group | Sham comparator | Other: symptomatic groupsymptomatic group : patients with systemic right ventricle and heart failure signs and/or decrease exercise performance |
| control | Sham comparator | Other: asymptomatic group, Other: symptomatic grouphealthy subject matched with patients of asymptomatic group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| asymptomatic group2 visits with MRI | Other | asymptomatic group, control |
| symptomatic group2 visits with MRI | Other | control, symptomatic group |
Primary outcome
remodelling indexes
Time frame: 48 months
wall stress index
Time frame: 48 months
fibrosis of systemic RV measured by MRI
Time frame: 48 months
4 secondary outcomes
echographic measures of RV function and geometry indexes
Time frame: 48 months
Arterial mechanical properties (stiffness aortic distensibility and arterial compliance)
Time frame: 48 months
Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides
Time frame: 48 months
Variability and reproducibility indices remodeling and wall stress MRI
Time frame: 48 months
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 1 Apr 2015.
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.
Magalie Ladouceur, MD principal investigator
Université Paris Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asymptomatic group and symptomatic group in people with Congenital Heart Disease With Systemic Right Ventricle, run by Assistance Publique - Hôpitaux de Paris 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?
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 1 Apr 2015. 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. Some participants in this study may receive a placebo. 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?
remodelling indexes (time frame: 48 months). The study lists 3 primary outcomes in all. 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 1 Apr 2015.