NCT03977428

Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Wuhan Asia Heart Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 80 Years
• Healthy volunteers: Not accepted

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）

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
OTHER	standard of care	No intervention, this a patient registry and is purely an observational study

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2019-06-06
• Last updated: 2021-04-14

Locations

1 site across 1 country: China