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

Save

Report Abuse

Description

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.

Targeted Conditions

Study Overview

Start Date
August 26, 2021
Completion Date
December 31, 2025
Enrollment
700
Date Posted
May 12, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing 100037, China

Eligibility

Study Population
Outpatients or inpatients with pulmonary hypertension
Minimum Age (years)
0.25
Maximum Age (years)
85
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;

Study Contact Info

Study Contact Name
Tingting Guo, M.D
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05372263