Multi-marker Approach for Risk Assessment in PAH

Recruiting

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT03954405
• Lead Sponsor: Wuhan Asia Heart Hospital

Brief Summary

Prospective registry including incident patients and prevalent patients which pretends to identify clinical characteristics, treatment trends in-hospital and ten years follow-up outcome through major adverse cardiovascular events (MACE) in a China population with well characterized PAH.

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

MACE 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: 2017-11-01
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-04-11
• Last Update Posted: 2021-04-13
• Primary Completion: 2023-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

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

Inclusion Criteria

diagnosis of PAH (by RHC)

Exclusion Criteria

Refusal 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 group 1 PAH cases. define the death as the primary outcome

Secondary Outcome Measures

Name	Time	Method
clinical worsening	5 years	one of the following: 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 WHO FC

Trial Locations

Locations (1)

Wuhan Asian Heart Hospital; 🇨🇳 Wuhan, China