Status:
RECRUITING
Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
3-85 years
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.
Eligibility Criteria
Inclusion
- 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
- Patients diagnosed with pulmonary hypertension related to left heart disease;
Key Trial Info
Start Date :
August 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT05372263
Start Date
August 26 2021
End Date
December 31 2026
Last Update
December 4 2025
Active Locations (1)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037