Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Prognostic value of the increased level of myocardial fibrosis
研究概览
简要总结
: Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.
Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.
Methods: 330 patients are planned to be included and followed for 2 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient with dilated cardiomyopathy and typical symptoms of cardiac insufficiency at the time of the diagnosis: oedemas of lower limbs, dyspnoea, asthenia.
- •and of a reduction in the fraction of ventricular ejection left (awkward) 45 % measured in echocardiography ( modified Simpson biplane) and associated with a volume télédiastolic volume superior to the normal in echocardiography: > 90ml / m2 ( modified Simpson biplane).
排除标准
- •Patients to whom the dysfunction VG is secondary or in a secondary overload of pressures in a HTA or a severe valvulopathie is in a coronary infringement(achievement), proved by histories of infarct or gestures(movements) of revascularisation (bypass(decking), stent) and or coronary hurts at least bi tronculaires significant the severity of which can explain the ventriculaire failure.
研究组 & 干预措施
Cardiomyopathy dilated patient
Cardiomyopathy dilated patients wil be evalueted by CMR using T1 mapping technique to evalueted the level myocardial fibrosis
干预措施: CMR using T1 mapping technique (Other)
healthy subjects
healthy subject wil be evaluated by CMR using T1 mapping technique to know the baseline of myocardial fibrosis in healthy subjects
干预措施: CMR using T1 mapping technique (Other)
结局指标
主要结局
Prognostic value of the increased level of myocardial fibrosis
时间窗: two years
The long-term forecast of the patients affected by CMD will be estimated by the survival without event. The events considered in this study are included in an associating combined criterion: * Death(Deaths), whatever is its cause. * The heart transplant * Hospitalization for cardiac cause, including acute(sharp) cardiac insufficiency, disorder(confusion) of the rhythm, required by rehabilitation of the treatment(processing), the thrombus ventriculaire left, cerebrovascular accident. * Palpitation ventriculaire steady (ventriculaire extrasystole \> 120 pulsation for minutes more than 30 on Holter of 24 hours(12 pm)). * Palpitation ventriculaire not steady
次要结局
- hemodynamic consequences of the increased level of myocardial fibrosis(txw years)