Study of Adaptation of the Right Ventricle to Systemic Afterload

Not Applicable

Completed

• Conditions: Congenital Heart Disease With Systemic Right Ventricle
• Interventions: Other: asymptomatic group; Other: symptomatic group

• 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

Study Timeline

• Study Start: 2011-02
• Status Verified: 2012-08
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2014-02-17
• Study First Posted: 2014-02-19
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	asymptomatic group	healthy subject matched with patients of asymptomatic group
symptomatic group	symptomatic group	symptomatic group : patients with systemic right ventricle and heart failure signs and/or decrease exercise performance
asymptomatic group	asymptomatic group	patients with systemic right ventricle who are asymptomatic,
control	symptomatic group	healthy subject matched with patients of asymptomatic group

Primary Outcome Measures

Name	Time	Method
remodelling indexes	48 months
fibrosis of systemic RV measured by MRI	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

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France