Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Adverse drug events [through study completion, an average of 6 months]
- All-cause Mortality [through study completion, an average of 6 months]
Eligibility Criteria
Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing | China | 100037 |
Sponsors and Collaborators
- China National Center for Cardiovascular Diseases
Investigators
- Principal Investigator: Lu Hua, M.D, Chinese Academy of Medical Sciences, Fuwai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CST2020CT303