New International CTEPH Database

NCT02656238 | Completed

• 1 other identifier: CTEPH Registry
• Study Type: observational
• Target: 1,019
• Locations: 21 countries
• Sites: 37

Brief 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. 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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension; CTEPH

Keywords

CTEPH; Balloon pulmonary angioplasty; Chronic thromboembolic pulmonary hypertension; Pulmonary endarterectomy; BPA; PEA

Outcome Measures

Primary Outcomes (3)

• Death

  Min. 3 years

• Lung transplantation

  Min. 3 years

• Change in New York Heart Association (NYHA) functional class

  Min 3. years

Secondary Outcomes (11)

• Age at diagnosis

  Min. 3 years

• Gender

  Min. 3 years

• Ethnicity

  Min. 3 years

• Disease severity

  Min. 3 years

• History of deep vein thrombosis (DVT)

  Min. 3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• None specified

Sponsors & Collaborators

• International CTEPH Association: lead

Study Sites (38)

UC San Diego

La Jolla, California, 92037-7892, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

St Vincent's Hospital

Darlinghurst, NSW 2010, Australia

Location

The Alfred Hospital

Prahran, 3181, Australia

Location

University Clinics of Vienna

Vienna, 1090, Austria

Location

University Hospitals of Leuven

Leuven, 3000, Belgium

Location

Hospital São Paulo, Federal University of São Paulo

São Paulo, 04023-062, Brazil

Location

University of Sao Paulo Medical School

São Paulo, 05403900, Brazil

Location

Toronto General Hospital

Toronto, Ontario, ON M5G 2C4, Canada

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Kasr Alaini School of Medicine

Cairo, 12411, Egypt

Location

Helsinki University Hospital

Helsinki, 00250, Finland

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

University of Pavia

Pavia, 27100, Italy

Location

Chiba University Hospital

Chiba, 260-8670, Japan

Location

Kobe University Graduate School of Medicine

Kobe, 750-0017, Japan

Location

National Hospital Organization Okayama

Okayama, 701-1192, Japan

Location

Kyorin University Hospital

Tokyo, 181-8611, Japan

Location

VU University Medical Center

Amsterdam, 1081, Netherlands

Location

Europejskim Centrum Zdrowia Otwock

Otwock, 05-400, Poland

Location

Medical University of Warsaw

Warsaw, 00-005, Poland

Location

Wojewódzki Szpital Specjalistyczny

Wroclaw, 51-124, Poland

Location

Cardiology Research Center

Moscow, 121552, Russia

Location

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

Novosibirsk, 630055, Russia

Location

Slovak Medical University and National Institute for Cardiovascular Diseases

Bratislava, 83348, Slovakia

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Hospital Clinic Barcelona

Barcelona, 8036, Spain

Location

Hospital Universitarion 12 Octubre

Madrid, 28041, Spain

Location

UniversitätsSpital Zürich

Zurich, 8005, Switzerland

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Marmara University School of Medicine

Istanbul, 34899, Turkey (Türkiye)

Location

Papworth Hospital

Cambridge, CB3 8RE, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, MW3 2QG, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34409094 RESULT

• 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.

  PMID: 39286890 DERIVED

Related Links

• Description of the registry on the website of the International CTEPH Association
• Abstract on long-term outcomes presented at ERS 2021

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: February 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

SL (1); KR (1); PL (3); NL (1); CA (1); EG (1); IT (1); TU (1); DK (1); DE (3); US (3); CH (1); GB (4); FI (1); ES (2); AU (2); BE (1); JP (4); TW (1); BR (2); RU (2)