Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-26 @ 1:16 PM
Ignite Modification Date: 2025-12-26 @ 1:16 PM
NCT ID: NCT02066506
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
Study: NCT02066506
Study Brief:
Protocol Section: NCT02066506