Prognosis of Isolated Left Ventricular Non-compaction in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Occurrence of death of cardiac origin
研究概览
简要总结
The main objective of this study is to clarify prospectively prognosis of patients newly diagnosed as carriers of a LVNC (incident cases) (i.e. without the occurrence of a survival of the following events: death, heart transplantation or hospitalization for cardiovascular complications). In a second time, prognosis factors will be identify in these patients with LVNC.
详细描述
Isolated Left Ventricular Non Compaction (LVNC) is a rare cause of cardiomyopathy supposed to result from the cessation of normal embryogenesis infarction, and characterized by persistent ventricular trabeculations prominent.
This is frequently a familial disease, but for which genetic characterization is still incomplete, and then requires the identification of new genes is desirable.
The prognosis of LVNC is uncertain, with a mortality rate reported in the literature ranging from 2 to 38%. Some series conclude that LVNC is a very severe heart disease, responsible for a high mortality, other that LVNC is frequently associated with a favorable prognosis. These series are however limited by the short duration of follow-up and the small number of patients included.
Between 2004 and 2006, a French registry LVNC, included 105 cases. It was found out that the LVNC was associated with a high rate of complications such as outbreaks of severe heart failure, need for heart transplantation, severe rhythm disorders, and embolic events. The prognosis of LVNC in France appears as pejorative:
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- there is no evidence that prognosis is different from other forms of cardiomyopathies.
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- the results of this register can be skewed by the inclusion of incident and prevalent cases (statistical survival bias).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged over 18 years
- •Presenting with Left Ventricular Non Compaction (LVNC, Group 1) or Idiopathic Dilated Cardiomyopathy (DCM, Group 2)
- •At distance of an acute heart failure thrust (> 1 month)
- •Newly diagnosed (less than 6 months)
- •Diagnosis confirmed by echocardiography associated or not with a Magnetic Resonance Imaging (MRI) confirmed after central review
- •Having signed informed consent form
排除标准
- •Age <18 years
- •Patients who were diagnosed more than 6 months ago (prevalent cases)
- •Presence of an associated cardiac disease, including valvular, ischemic, or congenital disease
- •Refusal to sign the informed consent form
结局指标
主要结局
Occurrence of death of cardiac origin
时间窗: Up to 2 years
Occurrence of hospitalization due to cardiac event
时间窗: Up to 2 years
Occurrence of a cardiac transplantation
时间窗: Up to 2 years
次要结局
未报告次要终点