NCT05372263招募中不适用
Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2021年8月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Adverse drug events
研究概览
简要总结
Recruit at least 700 PH patients, follow up every 6 months based on a computerized follow-up system. Primary outcomes are adverse drug events and all-cause death.
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
- 3 Months 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 3 months to 85 years, no sex preference;
- •Right heart catheter meet the following conditions simultaneously: mPAP≥25mmHg, and PVR > 3 Wood units(in children PVRi > 3 WU x m2), and PAWP≤15 mmHg at rest;
- •Patients diagnosed with group 1,2,4,5 PH according to the WHO classification, detailed description is as follows: Pulmonary arterial hypertension, Lung disease / chronic hypoxia associated pulmonary hypertension, Pulmonary hypertension associated with pulmonary artery stenosis / obstruction and Pulmonary hypertension caused by other multiple factors
- •Take at least one pulmonary hypertension targeted drug or calcium antagonist;
- •Signed written informed consent.
排除标准
- •Patients diagnosed with pulmonary hypertension related to left heart disease;
结局指标
主要结局
Adverse drug events
时间窗: through study completion, an average of 6 months
All-cause Mortality
时间窗: through study completion, an average of 6 months
次要结局
未报告次要终点
研究者
Lu Hua
Chief Physician
China National Center for Cardiovascular Diseases
研究点 (1)
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