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

NCT02186691 | Completed

• 1 other identifier: 2014-06
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetralogy of Fallot With Pulmonary Stenosis

Keywords

pulmonary valve replacement; tetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• determination of contractile reserve

  2.5 years

Other Outcomes (1)

• determnation of variation fibrosis biomarkers

  2.5 years

Study Arms (1)

RV and LV ejection fraction assesment

EXPERIMENTAL

assesment RV and LV ejection fraction after PVR measured by MRI

Other: MRI

Interventions

MRI OTHER

Also known as: assesment RV and LV ejection fraction after PVR

RV and LV ejection fraction assesment

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- older than 14 year-old, with repaired tetralogy of Fallot requiring pulmonary valve

You may not qualify if:

• liver failure, kidney failure,
• contra indication to MRI study,
• non-affiliated to the national health care program

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13005, France

Location

Related Publications (1)

• Habert P, Bentatou Z, Aldebert P, Finas M, Bartoli A, Bal L, Lalande A, Rapacchi S, Guye M, Kober F, Bernard M, Jacquier A. Exercise stress CMR reveals reduced aortic distensibility and impaired right-ventricular adaptation to exercise in patients with repaired tetralogy of Fallot. PLoS One. 2018 Dec 31;13(12):e0208749. doi: 10.1371/journal.pone.0208749. eCollection 2018.

  PMID: 30596647 RESULT

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Beatrice BONELLO, MD

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: July 10, 2014
• Study Start: September 15, 2014
• Primary Completion: October 18, 2019
• Study Completion: April 12, 2023
• Last Updated: May 8, 2026

Record last verified: 2023-04

Locations

FR (1)