RecruitingNCT05372263

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


Sponsor

China National Center for Cardiovascular Diseases

Enrollment

700 participants

Start Date

Aug 26, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 3 MonthsMax Age: 85 Years

Inclusion Criteria5

  • 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 Criteria1

  • Patients diagnosed with pulmonary hypertension related to left heart disease;

Locations(1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT05372263


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