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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

3 month–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Tingting Guo, M.D

CONTACT

[email protected]

+86 18610094559

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

Adverse drug events

Time frame: through study completion, an average of 6 months
All-cause Mortality

Time frame: through study completion, an average of 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Tingting Guo, M.D

CONTACT

[email protected]

+86 18610094559

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: May 12, 2022
Registry last updated: Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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