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

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ClinicalTrials.gov Identifier: NCT03977428
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Wuhan Asia Heart Hospital

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
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)


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Study Type : Observational
Estimated 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 : January 1, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023



Intervention Details:
  • Other: standard of care
    No intervention, this a patient registry and is purely an observational study


Primary Outcome Measures :
  1. survival [ Time Frame: 5 years ]
    To recruit a cohort of CHD-PAH cases. define the death as the primary outcome


Secondary Outcome Measures :
  1. clinical worsening [ Time Frame: 5 years ]
    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



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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with diagnosis of CHD-PAH
Criteria

Inclusion Criteria:

Diagnosis of CHD-PAH (by RHC)

Exclusion Criteria:

Refusal to participate.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977428


Contacts
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Contact: Zheng Xuan +8618627885144 soniazheng@outlook.com

Locations
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China
Wuhan Asian Heart Hospital Recruiting
Wuhan, China
Contact: Qiu qiu         
Principal Investigator: Zhang gangcheng         
Sponsors and Collaborators
Wuhan Asia Heart Hospital
Investigators
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Principal Investigator: Qiu Qiu Wuhan Asian Heart Hospital

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Responsible Party: Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT03977428     History of Changes
Other Study ID Numbers: 2019LMC-1
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Heart Diseases
Familial Primary Pulmonary Hypertension
Heart Defects, Congenital
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities