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

Tetralogy of Fallot With Pulmonary Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186691
• Other study ID #: 2014-06
• Status: Completed
• Phase: N/A
• Start date: September 15, 2014
• Est. completion date: April 12, 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 12, 2023
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Valve Stenosis
• Tetralogy of Fallot
• Tetralogy of Fallot With Pulmonary Stenosis
• Ventricular Remodeling

Intervention

Other:
• MRI

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	determnation of variation fibrosis biomarkers	determine if the fibrosis biomarkers dosage compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR	2.5 years
Primary	determination of the quantity of diffuse myocardial fibrosis	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	2.5 years
Secondary	determination of contractile reserve	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	2.5 years