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

Study Overview

• Status: Unknown
• Conditions: The Geodemographics of CTEPH in Taiwan

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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:

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

Study Plan

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	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	detail information descriptive in protocol	recruiting period two years

Collaborators and Investigators

• 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

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: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 201709016RIPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No