Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03977428

Acronym

CHD-PAHCS

Enrollment

500

Registered

2019-06-06

Start date

2019-01-01

Completion date

2023-06-30

Last updated

2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

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.

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）

Interventions

OTHERstandard of care

No intervention, this a patient registry and is purely an observational study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 80 Years

Healthy volunteers

Inclusion criteria

-Clinical diagnosis of CHD-PAH (by RHC)

Exclusion criteria

* PAH due to other criteria; * unable to participate

Design outcomes

Primary

Measure	Time frame	Description
survival	5 years	To recruit a cohort of CHD-PAH cases. define the death as the primary outcome

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactZheng Xuan

soniazheng@outlook.com+8618627885144

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026