Study of Adaptation of the Right Ventricle to Systemic Afterload
- Conditions
- Congenital Heart Disease With Systemic Right Ventricle
- Registration Number
- NCT02066506
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method fibrosis of systemic RV measured by MRI 48 months remodelling indexes 48 months wall stress index 48 months
- Secondary Outcome Measures
Name Time Method Arterial mechanical properties (stiffness aortic distensibility and arterial compliance) 48 months comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow
Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides 48 months Variability and reproducibility indices remodeling and wall stress MRI 48 months inter and intra-observer variability and inter-examination MRI measures
echographic measures of RV function and geometry indexes 48 months comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow
Related Research Topics
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Trial Locations
- Locations (1)
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hôpital Européen Georges Pompidou🇫🇷Paris, France