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NCT03977428 Clinical Trial

Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

Pulmonary Arterial Hypertension Clinical Trial

— CHD-PAHCS  

Official title:
Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03977428
Other study ID # 2019LMC-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date June 30, 2023

Study information
Verified date January 2021
Source Wuhan Asia Heart Hospital
Contact Zheng Xuan
Phone +8618627885144
Email soniazheng@outlook.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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）

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date June 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 80 Years
Eligibility Inclusion Criteria: -Clinical diagnosis of CHD-PAH (by RHC) Exclusion Criteria: - PAH due to other criteria; - unable to participate

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• standard of care
No intervention, this a patient registry and is purely an observational study

Locations
Country Name City State
China Wuhan Asian Heart Hospital Wuhan

Sponsors (1)
Lead Sponsor Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary survival To recruit a cohort of CHD-PAH cases. define the death as the primary outcome 5 years
Secondary clinical worsening 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 5 years
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