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

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ClinicalTrials.gov Identifier: NCT02186691
Recruitment Status : Unknown
Verified July 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tetralogy of Fallot With Pulmonary Stenosis Other: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot.
Study Start Date : May 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: RV and LV ejection fraction assesment
assesment RV and LV ejection fraction after PVR measured by MRI
Other: MRI
Other Name: assesment RV and LV ejection fraction after PVR




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. determination of contractile reserve [ Time Frame: 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


Other Outcome Measures:
  1. determnation of variation fibrosis biomarkers [ Time Frame: 2.5 years ]
    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



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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186691


Contacts
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Contact: Beatrice BONELLO, MD +3391386721 bbonello@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13005
Principal Investigator: Beatrice BONELLO, MD         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Beatrice BONELLO, MD Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02186691     History of Changes
Other Study ID Numbers: 2014-06
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014
Keywords provided by Assistance Publique Hopitaux De Marseille:
pulmonary valve replacement
tetralogy of Fallot
Additional relevant MeSH terms:
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Tetralogy of Fallot
Pulmonary Valve Stenosis
Ventricular Remodeling
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Valve Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical