Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
Primary Purpose
Tetralogy of Fallot With Pulmonary Stenosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Tetralogy of Fallot With Pulmonary Stenosis focused on measuring pulmonary valve replacement, tetralogy of Fallot
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RV and LV ejection fraction assesment
Arm Description
assesment RV and LV ejection fraction after PVR measured by MRI
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02186691
First Posted
June 4, 2014
Last Updated
April 12, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02186691
Brief Title
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
Official Title
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2014 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
April 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetralogy of Fallot With Pulmonary Stenosis
Keywords
pulmonary valve replacement, tetralogy of Fallot
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RV and LV ejection fraction assesment
Arm Type
Experimental
Arm Description
assesment RV and LV ejection fraction after PVR measured by MRI
Intervention Type
Other
Intervention Name(s)
MRI
Other Intervention Name(s)
assesment RV and LV ejection fraction after PVR
Primary Outcome Measure Information:
Title
determination of the quantity of diffuse myocardial fibrosis
Description
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
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
determination of contractile reserve
Description
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
Time Frame
2.5 years
Other Pre-specified Outcome Measures:
Title
determnation of variation fibrosis biomarkers
Description
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
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice BONELLO, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
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