免费获得国外相关药品，最快 1 个工作日回馈药物信息
Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study (CHD-PAHCS)
| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Arterial Hypertension | Other: standard of care |
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 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 |
- survival [ Time Frame: 5 years ]To recruit a cohort of CHD-PAH cases. define the death as the primary outcome
- clinical worsening [ Time Frame: 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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 4, 2019 | ||||
| First Posted Date | June 6, 2019 | ||||
| Last Update Posted Date | April 14, 2021 | ||||
| Actual Study Start Date | January 1, 2019 | ||||
| Estimated Primary Completion Date | December 30, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
survival [ Time Frame: 5 years ] To recruit a cohort of CHD-PAH cases. define the death as the primary outcome
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
clinical worsening [ Time Frame: 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
|
||||
| Original Secondary Outcome Measures |
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
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study | ||||
| Official Title | Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study | ||||
| 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） |
||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients with diagnosis of CHD-PAH | ||||
| Condition | Pulmonary Arterial Hypertension | ||||
| Intervention | Other: standard of care
No intervention, this a patient registry and is purely an observational study
|
||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 30, 2023 | ||||
| Estimated Primary Completion Date | December 30, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria: -Clinical diagnosis of CHD-PAH (by RHC) Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 1 Year to 80 Years (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03977428 | ||||
| Other Study ID Numbers | 2019LMC-1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Wuhan Asia Heart Hospital | ||||
| Study Sponsor | Wuhan Asia Heart Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | Wuhan Asia Heart Hospital | ||||
| Verification Date | January 2021 | ||||
