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

NCT ID: NCT05372263

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-26

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;
Minimum Eligible Age

3 Months

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lu Hua

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lu Hua, M.D

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tingting Guo, M.D

Role: CONTACT

+86 18610094559

Facility Contacts

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Tingting Guo, M.D

Role: primary

+86 18610094559

Other Identifiers

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CST2020CT303

Identifier Type: -

Identifier Source: org_study_id

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