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

NCT05372263 | Recruiting

• 1 other identifier: CST2020CT303
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Adverse drug events

  through study completion, an average of 6 months

• All-cause Mortality

  through study completion, an average of 6 months

Eligibility Criteria

• Age: 3 Months - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients or inpatients with pulmonary hypertension

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lu Hua, M.D

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Guo, M.D

CONTACT

+86 18610094559; 18610094559@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 12, 2022
• Study Start: August 26, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)