Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
Recruiting · NCT05372263 · Observational (researchers observe without assigning treatment) · Lead sponsor: China National Center for Cardiovascular Diseases
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
Age range
3 Months to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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;
Where it is running
1 location listed.
- Fuwai Hospital, Chinese Academy of Medical Sciences - Beijing, Beijing Municipality, China