Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Pulmonary Hypertension

Study type: Observational

Funder types: Other

Identifiers

NCT05372263

CST2020CT303

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 3 months to 85 years old

Volunteers: No Healthy Volunteers

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;