CardioMEMS Registry of the Frankfurt Heart Failure Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose
研究概览
简要总结
Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option. In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on mortality and morbidity in a routine clinical setting in Germany, the investigators initiated this multicenbtric registry.
详细描述
All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure parameters, lab values, medication and QoL as obtained on the regular outpatients visits in the department are entered into a registry-specific database.
The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL as well as on Guideline-recommended heart failure medication. In addition, it is planned to quantify the input in person time for telemonitoring.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implantation of CardioMEMS successful
- •Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe University)
排除标准
- •Unwillingness to participate in the registry
结局指标
主要结局
morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose
时间窗: 5 years
morbidity
次要结局
未报告次要终点
研究者
Birgit Assmus, PD Dr.
Prof. Dr. med.
Johann Wolfgang Goethe University Hospital