Study of Adaptation of the Right Ventricle to Systemic Afterload (STARS)

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

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease With Systemic Right Ventricle
• Intervention / Treatment: Other: asymptomatic group; Other: symptomatic group

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Européen Georges Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: asymptomatic group; patients with systemic right ventricle who are asymptomatic,	Other: asymptomatic group; 2 visits with MRI
Sham Comparator: symptomatic group; symptomatic group : patients with systemic right ventricle and heart failure signs and/or decrease exercise performance	Other: symptomatic group; 2 visits with MRI
Sham Comparator: control; healthy subject matched with patients of asymptomatic group	Other: asymptomatic group; 2 visits with MRI; Other: symptomatic group; 2 visits with MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
remodelling indexes	48 months
wall stress index	48 months
fibrosis of systemic RV measured by MRI	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides		48 months
Variability and reproducibility indices remodeling and wall stress MRI	inter and intra-observer variability and inter-examination MRI measures	48 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Magalie Ladouceur, MD, Université Paris Descartes

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: February 17, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: cardiac magnetic resonance imaging; congenital heart disease; systemic right ventricle
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: P080609