New International CTEPH Database

NCT ID: NCT02656238

Last Updated: 2022-08-08

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

COMPLETED

Total Enrollment

1019 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Thromboembolic Pulmonary Hypertension CTEPH

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* None specified
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International CTEPH Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UC San Diego

La Jolla, California, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

St Vincent's Hospital

Darlinghurst, , Australia

Site Status

The Alfred Hospital

Prahran, , Australia

Site Status

University Clinics of Vienna

Vienna, , Austria

Site Status

University Hospitals of Leuven

Leuven, , Belgium

Site Status

Hospital São Paulo, Federal University of São Paulo

São Paulo, , Brazil

Site Status

University of Sao Paulo Medical School

São Paulo, , Brazil

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Kasr Alaini School of Medicine

Cairo, , Egypt

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

Kerckhoff-Klinik GmbH

Bad Nauheim, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Universitätsklinikum des Saarlandes

Homburg, , Germany

Site Status

University of Pavia

Pavia, , Italy

Site Status

Chiba University Hospital

Chiba, , Japan

Site Status

Kobe University Graduate School of Medicine

Kobe, , Japan

Site Status

National Hospital Organization Okayama

Okayama, , Japan

Site Status

Kyorin University Hospital

Tokyo, , Japan

Site Status

VU University Medical Center

Amsterdam, , Netherlands

Site Status

Europejskim Centrum Zdrowia Otwock

Otwock, , Poland

Site Status

Medical University of Warsaw

Warsaw, , Poland

Site Status

Wojewódzki Szpital Specjalistyczny

Wroclaw, , Poland

Site Status

Cardiology Research Center

Moscow, , Russia

Site Status

Novosibirsk Research Institute of Circulation Pathology Academician E.N.Meshalkin

Novosibirsk, , Russia

Site Status

Slovak Medical University and National Institute for Cardiovascular Diseases

Bratislava, , Slovakia

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status

Hospital Universitarion 12 Octubre

Madrid, , Spain

Site Status

UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Marmara University School of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Papworth Hospital

Cambridge, , United Kingdom

Site Status

Western Infirmary

Glasgow, , United Kingdom

Site Status

Royal Free London NHS Foundation Trust

London, , United Kingdom

Site Status

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Site Status

Countries

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United States Australia Austria Belgium Brazil Canada Denmark Egypt Finland Germany Italy Japan Netherlands Poland Russia Slovakia South Korea Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

References

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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.

Reference Type RESULT
PMID: 34409094 (View on PubMed)

Delcroix 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.

Reference Type DERIVED
PMID: 39286890 (View on PubMed)

Related Links

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https://www.cteph-association.org/new-international-cteph-registry.html

Description of the registry on the website of the International CTEPH Association

Other Identifiers

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CTEPH Registry

Identifier Type: -

Identifier Source: org_study_id

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