French Hypertrophic Cardiomyopathy Observatory
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Event-free survival
研究概览
简要总结
Hypertrophic cardiomyopathy (Hypertrophic CardioMyopathy=HCM) remains a poorly understood disease with an assumption insufficiently codified. There is no data available in France on the profile of patients, diagnostic methods and assessment and therapeutic use.
The purpose of this study is to establish a monitoring of patients with HCM (sarcomere of origin or not) in France (diagnosis, treatment)
详细描述
This both retrospective and prospective study is proposed to cardiology services 50 hospitals in France. A cardiologist referral is designated for each facility.
The following data will be collected by the physician during the initial hospitalization
- Demographics
- Geographic origin of patient
- Clinical data: criteria for inclusion and non-inclusion data HCM general, Doppler ultrasound, personal history, family history
- Reviews made: non-organic, biological
- Family Survey,
- Treatments: Medical, Electrical, invasive
- Data from hospital
The follow-up to 18 months, 3 years and 5 years will be conducted by clinical-research-technicians of the French Society of Cardiology, an application will be made to municipalities of birth and mail a letter to physicians and patients.
The following data will be collected:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 15 years old
- •Patient with HCM defined by an ultrasound thickness of the left ventricle ≥ 13 mm if familial or ≥ 15 mm if sporadic
排除标准
- •Expressed refusal to participate in the study
- •Significant aortic stenosis (<1 cm ²)
结局指标
主要结局
Event-free survival
时间窗: 3 years
次要结局
- Diagnostic methods(0 day)
研究者
Hagege Albert
Professor
French Cardiology Society