Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03667391

Enrollment

200

Registered

2018-09-12

Start date

2018-01-17

Completion date

2022-01-01

Last updated

2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Geodemographics of CTEPH in Taiwan

Keywords

Chronic ThromboEmbolic Pulmonary Hypertension

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Taiwan

Contacts

Primary ContactHsao H Hsu, PhD

ntuhsu@gmail.com+886 972651420

Outcome results