Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03977428
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2019-06-04
Brief Title:
Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study
Sponsor:
Wuhan Asia Heart Hospital
Organization:
Wuhan Asia Heart Hospital
Study Overview
Official Title:
Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHD-PAHCS
Brief Summary:
The study will recruit and follow up patients for five years patients newly diagnosed with congenital heart disease associated pulmonary arterial hypertensionCHD-PAH from the investigators 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 heartlung 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
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 heartlung 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None