Recruitment

Recruitment Status
Completed

Exclusion Criterias

Counter-indication for performing a stress test
electrolytes
Patient with severe renal clearance less than Glomerular Filtration Rate inf 30ml/mn/1.73m²
...
Counter-indication for performing a stress test
electrolytes
Patient with severe renal clearance less than Glomerular Filtration Rate inf 30ml/mn/1.73m²
Primary or secondary cardiomyopathy-known or detectable on echocardiography
History of myocardial infarction-known or detectable on the ECG-abnormal Liver function tests
viral serology
Complete Blood Count
Patient has already made a severe allergy to gadolinium MRI contrast Current Pregnancy
History of thoracic radiotherapy or chemotherapy
Contraindications MRI

Summary

Conditions
Congenital Heart Disease With Systemic Right Ventricle
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 hypertrop...

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

Exclusion Criterias

Counter-indication for performing a stress test
electrolytes
Patient with severe renal clearance less than Glomerular Filtration Rate inf 30ml/mn/1.73m²
...
Counter-indication for performing a stress test
electrolytes
Patient with severe renal clearance less than Glomerular Filtration Rate inf 30ml/mn/1.73m²
Primary or secondary cardiomyopathy-known or detectable on echocardiography
History of myocardial infarction-known or detectable on the ECG-abnormal Liver function tests
viral serology
Complete Blood Count
Patient has already made a severe allergy to gadolinium MRI contrast Current Pregnancy
History of thoracic radiotherapy or chemotherapy
Contraindications MRI

Locations

Paris, 75015
Paris, 75015

Tracking Information

NCT #
NCT02066506
Collaborators
Not Provided
Investigators
  • Principal Investigator: Magalie Ladouceur, MD Université Paris Descartes
  • Magalie Ladouceur, MD Université Paris Descartes