The Geodemographics of CTEPH in TaiwanNCT03667391
Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry
An observational study of The Geodemographics of CTEPH in Taiwan, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- The Geodemographics of CTEPH in Taiwan
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jan 2018to 1 Jan 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- not written informed consent
- not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Hsao-Hsun Hsu, +886972651420, ntuhsu@gmail.com
About this study
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:
Read more
- 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
- Conditions
- The Geodemographics of CTEPH in Taiwan
- Keywords
- Chronic ThromboEmbolic Pulmonary Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: recruiting period two years
Secondary outcomes (1)
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
Measured: recruiting period two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start17 Jan 2018
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Geodemographics of CTEPH in TaiwanStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsao H Hsu, PhD, Principal investigator, No.7, Chung Shan S. Rd.（Zhongshan S. Rd.）, Zhongzheng Dist., Taipei City 10002, Taiwan (R.O.C.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667391
- Sponsor's protocol ID
- 201709016RIPC
- Status last verified
- Apr 2020
- First submitted
- 10 Sep 2018
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38252515
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry
- ClinicalTrials.gov ID
- NCT03667391
- Acronym / sponsor ID
- 201709016RIPC
- Conditions
- The Geodemographics of CTEPH in Taiwan
- Keywords
- Chronic ThromboEmbolic Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- not written informed consent
- not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Derived from this study: PubMed 38252515Yang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsao H Hsu, PhD principal investigator
No.7, Chung Shan S. Rd.（Zhongshan S. Rd.）, Zhongzheng Dist., Taipei City 10002, Taiwan (R.O.C.)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Geodemographics of CTEPH in Taiwan, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsao H Hsu, PhD (+886 972651420, ntuhsu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the geodemographics of CTEPH in Taiwan (time frame: recruiting period two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.