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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05372263
Enrollment
700
Registered
2022-05-12
Start date
2021-08-26
Completion date
2026-12-31
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

None listed

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 85 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frame
Adverse drug eventsthrough study completion, an average of 6 months
All-cause Mortalitythrough study completion, an average of 6 months

Countries

China

Contacts

Primary ContactTingting Guo, M.D
18610094559@163.com+86 18610094559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026