Berlin Registry of Right Heart Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall mortality
研究概览
简要总结
The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.
详细描述
The subject of the study is to register interventional therapies of right heart diseases (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin). Based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases, the impact on the patients' symptoms and life expectancy after interventions will be investigated. The aim is to identify patient subgroups that benefit the most.
Primary endpoints: Total mortality, cardiovascular mortality, heart failure hospitalization.
Secondary endpoints: NYHA class, NTproBNP, liver and kidney function (laboratory measurements), valve function, cardiac function, and cardiac morphology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis)
- •>18 years
- •Written, documented consent
排除标准
- •Patients in care or unable to consent
- •Patients who are unable to comply with follow-up examinations
- •Patients who are detained in an institution
结局指标
主要结局
Overall mortality
时间窗: 2 months after intervention
Number of deceased participants after 2 months after intervention
Cardiovascular mortality
时间窗: 2 months after intervention
Number of deceased participants after 2 months after intervention (cardiovascular cause of mortality)
Unscheduled hospitalization for heart failure progression
时间窗: 2 months after intervention
Number of participants with unscheduled hospitalization for heart failure progression after 2 months after intervention
次要结局
- valve function(2 months after intervention)
- NYHA class(2 months after intervention)
- liver function(2 months after intervention)
- cardiac function(2 months after intervention)
- NTproBNP(2 months after intervention)
- kidney function(2 months after intervention)
- cardiac morphology(2 months after intervention)
研究者
Prof. Dr. Henryk Dreger
Professor
Charite University, Berlin, Germany