The Geodemographics of CTEPH in Taiwan Clinical Trial
Official title:
Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry
The diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) is difficult for
numerous reasons and is related with a poor prognosis. In Taiwan, the incidence of CTEPH and
its clinical features are unknown. This study aims at evaluating the prevalence, clinical
characteristics, and management of CTEPH in a Taiwanese cohort.
Primary objective:
- To investigate the geodemographics of CTEPH in Taiwan
Secondary objectives:
- To characterize the demographics and clinical presentation of patients with CTEPH
- To describe the real-world management and treatment outcome of patients with CTEPH
- To identify the risk factors of CTEPH
- To assess the relationship between risk factors/patients' characteristics and clinical
outcomes for CTEPH
- To evaluate the prognosis of CTEPH in Taiwan using survival assessment
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | January 1, 2022 |
| Est. primary completion date | January 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: 1. Right heart catheterization (RHC) results that are in line with both of the following haemodynamic levels: Mean pulmonary arterial pressure (mPAP) = 25 mmHg at rest AND Pulmonary arterial wedge pressure (PAWP) = 15 mmHg 2. Confirmation of CTEPH diagnosis by one of the following as recommended by standard guidelines: At least 1 (segmental) perfusion defect(s) in ventilation-perfusion (V/Q) / perfusion scan OR Pulmonary artery obstruction seen by multidetector computed tomography (MDCT) angiography or conventional pulmonary cineangiography. 3. Presence of pulmonary hypertension or evidence of pulmonary thromboembolism after at least 3 months of anticoagulation treatment. Exclusion Criteria: - not written informed consent - not meet inclusion criteria |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To investigate the geodemographics of CTEPH in Taiwan | variables of interest also include (1) patients characteristics, such as demographics and medical history; (2) clinical features and diagnosis records, such as risk factors, comorbidities, CTEPH diagnosis data, concomitant conditions; (3) management of CTEPH, including surgery and medication; and (4) clinical outcome including clinical assessment results, survival status, and clinical worsening related to CTEPH. | recruiting period two years | |
| Secondary | To characterize the demographics and clinical presentation of patients with CTEPH - To describe the real-world management and treatment outcome of patients with CTEPH - To identify the risk factors of CTEPH - To assess the relationship between risk f | detail information descriptive in protocol | recruiting period two years |