Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT03977428
• Lead Sponsor: Wuhan Asia Heart Hospital

Brief Summary

The study will recruit and follow up patients for five years patients newly diagnosed with congenital heart disease associated pulmonary arterial hypertension(CHD-PAH) from the investigator's hospital. The main aim of the study is to describe the aetiology, natural history and management practices of CHD-PAH in central China.

Detailed Description

baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart.

Lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases.

Right heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests

main outcome measure include:

death heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of \>15% from baseline in 6MWD (or \>30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-04-11
• Last Update Posted: 2021-04-14
• Primary Completion: 2022-12-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

-Clinical diagnosis of CHD-PAH (by RHC)

Exclusion Criteria

• PAH due to other criteria;
• unable to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival	5 years	To recruit a cohort of CHD-PAH cases. define the death as the primary outcome

Secondary Outcome Measures

Name	Time	Method
clinical worsening	5 years	number of patients were dead, or having heart/lung transplantation, atrial septostomy, hospitalization due to worsening of PAH, starting of new specific PAH treatment, persistent decrease of \>15% from baseline in 6MWD (or \>30% compared with last study-related measurement), persistent worsening of WHO FC

Trial Locations

Locations (1)

Wuhan Asian Heart Hospital; 🇨🇳 Wuhan, China