Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry

April 23, 2020 updated by: National Taiwan University Hospital

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

Study Overview

Status

Unknown

Conditions

The Geodemographics of CTEPH in Taiwan

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital
    - Contact:
      
      Hsao-Hsun Hsu
      
      Phone Number: +886972651420
      
      Email: ntuhsu@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with contrast CT image and cardiac echo data and confirmed/suspected as CTEPH can be included in the screening (initial registration). Those who have confirmed diagnosis of CTEPH in expert centers (IRB approved for patient enrollment) will be enrolled into the study.

Description

Inclusion Criteria:

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
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.
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the geodemographics of CTEPH in Taiwan Time Frame: 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.	recruiting period two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: recruiting period two years	detail information descriptive in protocol	recruiting period two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

Principal Investigator: Hsao H Hsu, PhD, No.7, Chung Shan S. Rd.（Zhongshan S. Rd.）, Zhongzheng Dist., Taipei City 10002, Taiwan (R.O.C.)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2018

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Chronic ThromboEmbolic Pulmonary Hypertension

Additional Relevant MeSH Terms

Other Study ID Numbers

201709016RIPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.