Chronic Thromboembolic Pulmonary HypertensionNCT02656238
New International CTEPH Database
An observational study of Chronic Thromboembolic Pulmonary Hypertension and CTEPH, run by International CTEPH Association at 38 sites in 22 countries.
Trial summary
The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, CTEPH
- How many people
- 1,019 participants
- Where
- 38 sitesin 22 countries
- Study dates
- Feb 2015to Jan 2020
- How long will I take part?
- 3 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients recently diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), meeting the registry's inclusion criteria, are eligible for inclusion into the New International CTEPH Database. Only newly diagnosed, i.e. incident patients are eligible for inclusion. A patient is considered an incident patient if a diagnostic heart catheterization was performed within 1 year prior to the initial inclusion visit (for the first patient included) at the site participating in the New International CTEPH Database.
Who may be able to join
- Patients must be newly diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) (incident patients)
- Patients must have been treated with anti-coagulation for at least 3 months before diagnosis of CTEPH
- Patients must be willing to provide informed consent
- Patients must meet the following criteria for CTEPH:
- Mean pulmonary artery pressure (PAP) ≥ 25 mmHg at rest
- Abnormal VQ scan, pulmonary angiogram, computed tomography (CT) pulmonary angiogram, or magnetic resonance (MR) pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
Who cannot join
- None specified
Trial locations and contacts
38 sites in 22 countries.
38 sites in 22 countries
Japan4 sites
Chiba University Hospital
Chiba, 260-8670
Kobe University Graduate School of Medicine
Kobe, 750-0017
National Hospital Organization Okayama
Okayama, 701-1192
Kyorin University Hospital
Tokyo, 181-8611
United Kingdom4 sites
Papworth Hospital
Cambridge, CB3 8RE
Western Infirmary
Glasgow, G11 6NT
Royal Free London NHS Foundation Trust
London, MW3 2QG
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
United States3 sites
University of Maryland
Baltimore, Maryland, 21201
Cleveland Clinic
Cleveland, Ohio, 44195
UC San Diego
La Jolla, California, 92037-7892
Germany3 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum des Saarlandes
Homburg, 66421
Poland3 sites
Europejskim Centrum Zdrowia Otwock
Otwock, 05-400
Medical University of Warsaw
Warsaw, 00-005
Wojewódzki Szpital Specjalistyczny
Wroclaw, 51-124
Australia2 sites
St Vincent's Hospital
Darlinghurst, NSW 2010
The Alfred Hospital
Prahran, 3181
Brazil2 sites
Hospital São Paulo, Federal University of São Paulo
São Paulo, 04023-062
University of Sao Paulo Medical School
São Paulo, 05403900
Russia2 sites
Cardiology Research Center
Moscow, 121552
Novosibirsk Research Institute of Circulation Pathology Academician E.N.Meshalkin
Novosibirsk, 630055
Spain2 sites
Hospital Clinic Barcelona
Barcelona, 8036
Hospital Universitarion 12 Octubre
Madrid, 28041
Slovakia1 site
Slovak Medical University and National Institute for Cardiovascular Diseases
Bratislava, 83348
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul, 34899
About this study
The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival.
The data collected will improve the knowledge and understanding of this condition, support the further development of diagnosis and treatment guidelines for patients with CTEPH, and contribute to improving patient care in the long-term.
- Keywords
- CTEPH, Balloon pulmonary angioplasty, Chronic thromboembolic pulmonary hypertension, Pulmonary endarterectomy, BPA, PEA
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: Min. 3 years
Lung transplantation
Measured: Min. 3 years
Change in New York Heart Association (NYHA) functional class
Measured: Min 3. years
Secondary outcomes (11)
Age at diagnosis
Measured: Min. 3 years
Gender
Measured: Min. 3 years
Ethnicity
Measured: Min. 3 years
Disease severity
As measured by New York Heart Association (NYHA) functional class
Measured: Min. 3 years
History of deep vein thrombosis (DVT)
Measured: Min. 3 years
History of acute pulmonary embolism
Measured: Min. 3 years
Hemodynamic parameters
Measured: Min. 3 years
Patient on oxygen (yes/no)
Measured: Min. 3 years
Medical treatment
e.g. mono- versus combination therapy
Measured: Min. 3 years
Pulmonary endarterectomy (PEA)
e.g. operated versus non-operated
Measured: Min. 3 years
Balloon pulmonary angioplasty (BPA)
e.g. BPA versus pulmonary endarterectomy (PEA)
Measured: Min. 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- 1,019 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- International CTEPH Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656238
- Sponsor's protocol ID
- CTEPH Registry
- Status last verified
- Aug 2022
- First submitted
- 12 Jan 2016
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Guth S, D'Armini AM, Delcroix M, Nakayama K, Fadel E, Hoole SP, Jenkins DP, Kiely DG, Kim NH, Lang IM, Madani MM, Matsubara H, Ogawa A, Ota-Arakaki JS, Quarck R, Sadushi-Kolici R, Simonneau G, Wiedenroth CB, Yildizeli B, Mayer E, Pepke-Zaba J. Current strategies for managing chronic thromboembolic pulmonary hypertension: results of the worldwide prospective CTEPH Registry. ERJ Open Res. 2021 Aug 16;7(3):00850-2020. doi: 10.1183/23120541.00850-2020. eCollection 2021 Jul.
PubMed 34409094Delcroix M, Pepke-Zaba J, D'Armini AM, Fadel E, Guth S, Hoole SP, Jenkins DP, Kiely DG, Kim NH, Madani MM, Matsubara H, Nakayama K, Ogawa A, Ota-Arakaki JS, Quarck R, Sadushi-Kolici R, Simonneau G, Wiedenroth CB, Yildizeli B, Mayer E, Lang IM. Worldwide CTEPH Registry: Long-Term Outcomes With Pulmonary Endarterectomy, Balloon Pulmonary Angioplasty, and Medical Therapy. Circulation. 2024 Oct 22;150(17):1354-1365. doi: 10.1161/CIRCULATIONAHA.124.068610. Epub 2024 Sep 17.
PubMed 39286890
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New International CTEPH Database
- ClinicalTrials.gov ID
- NCT02656238
- Acronym / sponsor ID
- CTEPH Registry
- Keywords
- CTEPH, Balloon pulmonary angioplasty, Chronic thromboembolic pulmonary hypertension, Pulmonary endarterectomy, BPA, PEA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,019 participants (actual)
- Lead sponsor
- International CTEPH AssociationUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 14 Jan 2016 (estimated)
- 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 New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival.
The data collected will improve the knowledge and understanding of this condition, support the further development of diagnosis and treatment guidelines for patients with CTEPH, and contribute to improving patient care in the long-term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients recently diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), meeting the registry's inclusion criteria, are eligible for inclusion into the New International CTEPH Database. Only newly diagnosed, i.e. incident patients are eligible for inclusion. A patient is considered an incident patient if a diagnostic heart catheterization was performed within 1 year prior to the initial inclusion visit (for the first patient included) at the site participating in the New International CTEPH Database.
Key inclusion criteria (6 listed)
- Patients must be newly diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) (incident patients)
- Patients must have been treated with anti-coagulation for at least 3 months before diagnosis of CTEPH
- Patients must be willing to provide informed consent
- Patients must meet the following criteria for CTEPH:
Key exclusion criteria (1 listed)
- None specified
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
Death
Time frame: Min. 3 years
Lung transplantation
Time frame: Min. 3 years
Change in New York Heart Association (NYHA) functional class
Time frame: Min 3. years
11 secondary outcomes
Age at diagnosis
Time frame: Min. 3 years
Gender
Time frame: Min. 3 years
Ethnicity
Time frame: Min. 3 years
Disease severity
Time frame: Min. 3 years
History of deep vein thrombosis (DVT)
Time frame: Min. 3 years
History of acute pulmonary embolism
Time frame: Min. 3 years
Hemodynamic parameters
Time frame: Min. 3 years
Patient on oxygen (yes/no)
Time frame: Min. 3 years
Medical treatment
Time frame: Min. 3 years
Pulmonary endarterectomy (PEA)
Time frame: Min. 3 years
Balloon pulmonary angioplasty (BPA)
Time frame: Min. 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Results publication: PubMed 34409094Guth S, D'Armini AM, Delcroix M, Nakayama K, Fadel E, Hoole SP, Jenkins DP, Kiely DG, Kim NH, Lang IM, Madani MM, Matsubara H, Ogawa A, Ota-Arakaki JS, Quarck R, Sadushi-Kolici R, Simonneau G, Wiedenroth CB, Yildizeli B, Mayer E, Pepke-Zaba J. Current strategies for managing chronic thromboembolic pulmonary hypertension: results of the worldwide prospective CTEPH Registry. ERJ Open Res. 2021 Aug 16;7(3):00850-2020. doi: 10.1183/23120541.00850-2020. eCollection 2021 Jul.
- Derived from this study: PubMed 39286890Delcroix M, Pepke-Zaba J, D'Armini AM, Fadel E, Guth S, Hoole SP, Jenkins DP, Kiely DG, Kim NH, Madani MM, Matsubara H, Nakayama K, Ogawa A, Ota-Arakaki JS, Quarck R, Sadushi-Kolici R, Simonneau G, Wiedenroth CB, Yildizeli B, Mayer E, Lang IM. Worldwide CTEPH Registry: Long-Term Outcomes With Pulmonary Endarterectomy, Balloon Pulmonary Angioplasty, and Medical Therapy. Circulation. 2024 Oct 22;150(17):1354-1365. doi: 10.1161/CIRCULATIONAHA.124.068610. Epub 2024 Sep 17.
- Description of the registry on the website of the International CTEPH AssociationLink provided by the sponsor.
Related trials for Chronic Thromboembolic Pulmonary Hypertension
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Not yet recruiting
CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
Active, not recruitingObservational study
TrEatment Approach in the Multimodal Era Registry
Chronic Thromboembolic Pulmonary Hypertension, CTEPH
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
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.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension and CTEPH, run by International CTEPH Association at 38 sites in 22 countries.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Japan, United Kingdom, United States, Germany, Poland and 17 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Min. 3 years). The study lists 3 primary outcomes in all. 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 NCT02656238, which also lists 2 linked publications.
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 8 Aug 2022.