Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry

NCT ID: NCT03667391

Last Updated: 2020-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-17

Study Completion Date

2022-01-01

Brief Summary

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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

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Conditions

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The Geodemographics of CTEPH in Taiwan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsao H Hsu, PhD

Role: PRINCIPAL_INVESTIGATOR

No.7, Chung Shan S. Rd.(Zhongshan S. Rd.), Zhongzheng Dist., Taipei City 10002, Taiwan (R.O.C.)

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsao H Hsu, PhD

Role: CONTACT

+886 972651420

Facility Contacts

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Hsao-Hsun Hsu

Role: primary

+886972651420

References

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Yang KM, Wang MT, Tao CW, Wu YJ, Hsu CH, Liao WC, Hsu HH, Lin MC, Tsai FT, Fu YJ, Kuo FY, Cheng CC, Hung CC, Wang HC, Yu CJ, Huang WC. The long-term outcome of chronic thromboembolic pulmonary hypertension: Pulmonary endarterectomy and balloon pulmonary angioplasty. J Chin Med Assoc. 2024 Mar 1;87(3):273-279. doi: 10.1097/JCMA.0000000000001059. Epub 2024 Jan 22.

Reference Type DERIVED
PMID: 38252515 (View on PubMed)

Other Identifiers

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201709016RIPC

Identifier Type: -

Identifier Source: org_study_id

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