CHD-PAHCS: Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

• Sponsor: Wuhan Asia Heart Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03977428
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 53.9
• Patients Per Site Per Month: 9.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Other: standard of care

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Outcome Measures

Primary Outcome Measures

1. survival [5 years]

   To recruit a cohort of CHD-PAH cases. define the death as the primary outcome

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

-Clinical diagnosis of CHD-PAH (by RHC)

Exclusion Criteria:

• PAH due to other criteria;

• unable to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wuhan Asian Heart Hospital	Wuhan		China

Sponsors and Collaborators

• Wuhan Asia Heart Hospital

Investigators

• Principal Investigator: Qiu Qiu, Wuhan Asian Heart Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wuhan Asia Heart Hospital
• ClinicalTrials.gov Identifier: NCT03977428
• Other Study ID Numbers: 2019LMC-1
• First Posted: Jun 6, 2019
• Last Update Posted: Apr 14, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Heart Diseases; Heart Defects, Congenital

Study Results

No Results Posted as of Apr 14, 2021