Safety Surveillance of Targeted Drugs for Pulmonary Hyper... | NCT05372263

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

NCT05372263

Sponsor

China National Center for Cardiovascular Diseases

Status

Recruiting

Last Update Posted

Dec 4, 2025Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Pulmonary Hypertension

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2021Actual

Primary Completion Date

Aug 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 28, 2022

First Submission Date that Met QC Criteria

May 8, 2022

First Posted Date

May 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lu Hua, Chief Physician, China National Center for Cardiovascular DiseasesPrincipal Investigator

Lead Sponsor

China National Center for Cardiovascular DiseasesOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse drug events		through study completion, an average of 6 months
All-cause Mortality		through study completion, an average of 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Outpatients or inpatients with pulmonary hypertension

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tingting Guo, M.D	Contact	+86 18610094559		18610094559@163.com

Overall Officials

Name	Affiliation	Role
Lu Hua, M.D	Chinese Academy of Medical Sciences, Fuwai Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fuwai Hospital, Chinese Academy of Medical Sciences	Recruiting	Beijing	Beijing Municipality	100037	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided