Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot

Not Applicable

Completed

• Conditions: Tetralogy of Fallot With Pulmonary Stenosis
• Interventions: Other: MRI

• Registration Number: NCT02186691
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-10
• Study Start: 2014-09-15
• Primary Completion: 2019-10-18
• Status Verified: 2023-04
• Study Completion: 2023-04-12
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RV and LV ejection fraction assesment	MRI	assesment RV and LV ejection fraction after PVR measured by MRI

Primary Outcome Measures

Name	Time	Method
determination of the quantity of diffuse myocardial fibrosis	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 Outcome Measures

Name	Time	Method
determination of contractile reserve	2.5 years	determine if contractile reserve 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

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France