Congenital Heart Disease With Systemic Right Ventricle Clinical Trial
— STARSOfficial title:
Study of Adaptation of the Right Ventricle to Systemic Afterload
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
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Européen Georges Pompidou | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | remodelling indexes | 48 months | No | |
| Primary | wall stress index | 48 months | No | |
| Primary | fibrosis of systemic RV measured by MRI | 48 months | No | |
| Secondary | 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 | 48 months | No |
| Secondary | 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 | 48 months | No |
| Secondary | Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides | 48 months | No | |
| Secondary | Variability and reproducibility indices remodeling and wall stress MRI | inter and intra-observer variability and inter-examination MRI measures | 48 months | No |