Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry

• Conditions: The Geodemographics of CTEPH in Taiwan

• Registration Number: NCT03667391
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-17
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

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Exclusion Criteria

• not written informed consent
• not meet inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the geodemographics of CTEPH in Taiwan	recruiting period two years	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.

Secondary Outcome Measures

Name	Time	Method
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	recruiting period two years	detail information descriptive in protocol

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan