NCT05372263 Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
| NCT ID | NCT05372263 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Pulmonary Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2021-08-26 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2021-08-26 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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;
Contact & Investigator
Lu Hua, M.D
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT05372263 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 85 Years, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05372263 currently recruiting?
Yes, NCT05372263 is actively recruiting participants. Contact the research team at 18610094559@163.com for enrollment information.
Where is the NCT05372263 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05372263 clinical trial?
NCT05372263 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Lu Hua, M.D at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 700 participants.