Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
Recruiting
- Conditions
- Pulmonary Hypertension
- Registration Number
- NCT05372263
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
- 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.
Exclusion Criteria
- Patients diagnosed with pulmonary hypertension related to left heart disease;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse drug events through study completion, an average of 6 months All-cause Mortality through study completion, an average of 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fuwai Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China