跳至主要内容
临床试验/NCT02186691
NCT02186691已完成不适用

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

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2014年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
determination of the quantity of diffuse myocardial fibrosis

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
14 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

RV and LV ejection fraction assesment

Experimental

assesment RV and LV ejection fraction after PVR measured by MRI

干预措施: MRI (Other)

结局指标

主要结局

determination of the quantity of diffuse myocardial fibrosis

时间窗: 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

次要结局

  • determination of contractile reserve(2.5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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