Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT02066506
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02066506
Study Brief:
Protocol Section:
NCT02066506