Monitoring the safety of targeted drugs for pulmonary hypertension using a computerized system
Official title: Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
Run by China National Center for Cardiovascular Diseases · NCT05372263 · Data updated 2026-11-12
This study is trying to see how safe targeted drugs are for people with pulmonary hypertension by following at least 700 patients over time using a computerized system.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Months to 85 Years |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 26, 2021 |
| Main results expected | August 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT05372263 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 3 months to 85 years diagnosed with specific types of pulmonary hypertension who are receiving targeted drug therapy.
✕Probably not a fit
Patients with pulmonary hypertension related to left heart disease will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to recruit at least 700 patients diagnosed with various forms of pulmonary hypertension and follow them up every six months using a computerized follow-up system. The primary focus is to monitor adverse drug events and all-cause mortality among participants receiving targeted therapies. By systematically collecting and analyzing data, the study seeks to enhance understanding of the safety profiles of these medications in a real-world setting. The study will include patients aged from 3 months to 85 years who meet specific diagnostic criteria.
Why it matters
Potential benefit: If successful, this study could improve the safety monitoring of targeted therapies for pulmonary hypertension, leading to better patient outcomes.
How similar studies have gone: Other studies have shown success in monitoring drug safety in similar patient populations, indicating that this approach is both relevant and potentially beneficial.
Who can join: the full rules
Show full inclusion / exclusion 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;
Where it's running
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Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Lu Hua, M.D — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Tingting Guo, M.D
- Email: 18610094559@163.com
- Phone: +86 18610094559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.