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NCT03954405 Clinical Trial

Multi-marker Approach for Risk Assessment in PAH

Pulmonary Arterial Hypertension Clinical Trial

— MARS  

Official title:
Multi-marker Approach for Risk Assessment in Pulmonary Arterial Hypertension (PAH)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03954405
Other study ID # 2018LMC-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date December 30, 2025

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

Clinical Trial 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.

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）

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 30, 2025
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year to 85 Years
Eligibility Inclusion Criteria: diagnosis of PAH (by RHC) Exclusion Criteria: Refusal to participate.

Study Design

Related Conditions & MeSH terms

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 group 1 PAH cases. define the death as the primary outcome 5 years
Secondary clinical worsening 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 5 years
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