Pulmonary Arterial HypertensionCHD-PAHCSNCT03977428
Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study
An observational study of Pulmonary Arterial Hypertension, run by Wuhan Asia Heart Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with diagnosis of CHD-PAH
Who may be able to join
- -Clinical diagnosis of CHD-PAH (by RHC)
Who cannot join
- PAH due to other criteria;
- unable to participate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Asian Heart Hospital
Wuhan
Qiu qiu
Zhang gangcheng
About this study
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）
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- standard of care
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
No intervention, this a patient registry and is purely an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
To recruit a cohort of CHD-PAH cases. define the death as the primary outcome
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jan 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiu Qiu, Principal investigator, Wuhan Asian Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977428
- Sponsor's protocol ID
- 2019LMC-1
- Acronym
- CHD-PAHCS
- Status last verified
- Jan 2021
- First submitted
- 4 Jun 2019
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study
- ClinicalTrials.gov ID
- NCT03977428
- Acronym / sponsor ID
- CHD-PAHCS / 2019LMC-1
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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）
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with diagnosis of CHD-PAH
Key inclusion criteria (1 listed)
- -Clinical diagnosis of CHD-PAH (by RHC)
Key exclusion criteria (2 listed)
- PAH due to other criteria;
- unable to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of careNo intervention, this a patient registry and is purely an observational study | Other | – |
Primary outcome
survival
Time frame: 5 years
To recruit a cohort of CHD-PAH cases. define the death as the primary outcome
1 secondary outcome
clinical worsening
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiu Qiu principal investigator
Wuhan Asian Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Wuhan Asia Heart Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Xuan (+8618627885144, soniazheng@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.