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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372263
• Other study ID #: CST2020CT303
• Status: Recruiting
• Start date: August 26, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Tingting Guo, M.D
• Phone: +86 18610094559
• Email: 18610094559[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse drug events		through study completion, an average of 6 months
Primary	All-cause Mortality		through study completion, an average of 6 months