Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tetralogy of Fallot With Pulmonary Stenosis
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- determination of the quantity of diffuse myocardial fibrosis
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at 35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or pulmonary regurgitation (PR). It is well established that these lesions can lead to irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve replacement technique was developed to avoid long term right ventricular dysfunction. Pulmonary valve replacement indications are based upon the presence of symptoms at exercise and/or morphological or functional parameters such as severe pulmonary regurgitation with right ventricle dilatation/dysfunction. The best timing of such intervention is still underdebate with the main aim of having the right balance between avoiding long term sequelae of PR or PS and being the latter possible to push ahead the need for new intervention. Recent publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging is feasible and could help the physician to best determine the right timing for PVR in this population of patients. Cardiac function assessment at rest and during exercise is possible using MR and our centre has developed a program for cardiac exercise during MRI. This could help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.
Investigators
Eligibility Criteria
Inclusion Criteria
- •older than 14 year-old, with repaired tetralogy of Fallot requiring pulmonary valve
Exclusion Criteria
- •liver failure, kidney failure,
- •contra indication to MRI study,
- •non-affiliated to the national health care program
Outcomes
Primary Outcomes
determination of the quantity of diffuse myocardial fibrosis
Time Frame: 2.5 years
determine if the quantity of diffuse myocardial fibrosis measured by cardiac magnetic resonnance (CMR) compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR
Secondary Outcomes
- determination of contractile reserve(2.5 years)