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Status unknownNCT03977428CHD-PAHCSUpdated Apr 14, 2021

Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

An observational study in Pulmonary Arterial Hypertension, sponsored by Wuhan Asia Heart Hospital. Status unknown at 1 site in China. Open to participants aged 1 Year to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-14.

Sponsored by Wuhan Asia Heart Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
1 Year to 80 Years
Sex
All
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Study 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.

Read the 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)

02

Conditions studied

  • Pulmonary Arterial Hypertension
03

In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's planned enrollment of 500 is above the median of 104 across 181 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Wuhan Asia Heart Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with diagnosis of CHD-PAH

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-Clinical diagnosis of CHD-PAH (by RHC)

Exclusion criteria

Exclusion Criteria:

  • PAH due to other criteria;
  • unable to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • Otherstandard of care

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

06

What researchers measure

Primary outcomes

  1. survival

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

    Time frame: 5 years

Secondary outcomes

  1. clinical worsening

    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

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Wuhan Asian Heart Hospital
    Wuhan, China
    Recruiting
    • Qiu qiu · Contact
    • Zhang gangcheng · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Dec 2022, 47 months after the start.

Of 64 non-industry observational studies under Pulmonary Arterial Hypertension, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 31. This study's planned 47 months is below that.

Counting every sponsor, half of 85 studies reached it within 58 months; a quarter within 30 and three quarters within 93.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2019
First posted
Jun 6, 2019
StartActual
Jan 1, 2019
Primary completionEst.
Dec 30, 2022
CompletionEst.
Jun 30, 2023
Last update
Apr 14, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03977428
Lead sponsor
Wuhan Asia Heart Hospital
Responsible party
Sponsor
First posted
Jun 6, 2019
Start date
Jan 1, 2019
Primary completion
Dec 30, 2022 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Apr 14, 2021

Study contacts

Zheng Xuan
Contact
soniazheng@outlook.com
+8618627885144
Qiu Qiu
principal investigator · Wuhan Asian Heart Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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