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New International CTEPH Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02656238
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : June 17, 2020
Information provided by (Responsible Party):
International CTEPH Association

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.

Condition or disease
Chronic Thromboembolic Pulmonary Hypertension CTEPH

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1019 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: New International CTEPH Database
Study Start Date : February 2015
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Primary Outcome Measures :
  1. Death [ Time Frame: Min. 3 years ]
  2. Lung transplantation [ Time Frame: Min. 3 years ]
  3. Change in New York Heart Association (NYHA) functional class [ Time Frame: Min 3. years ]

Secondary Outcome Measures :
  1. Age at diagnosis [ Time Frame: Min. 3 years ]
  2. Gender [ Time Frame: Min. 3 years ]
  3. Ethnicity [ Time Frame: Min. 3 years ]
  4. Disease severity [ Time Frame: Min. 3 years ]
    As measured by New York Heart Association (NYHA) functional class

  5. History of deep vein thrombosis (DVT) [ Time Frame: Min. 3 years ]
  6. History of acute pulmonary embolism [ Time Frame: Min. 3 years ]
  7. Hemodynamic parameters [ Time Frame: Min. 3 years ]
  8. Patient on oxygen (yes/no) [ Time Frame: Min. 3 years ]
  9. Medical treatment [ Time Frame: Min. 3 years ]
    e.g. mono- versus combination therapy

  10. Pulmonary endarterectomy (PEA) [ Time Frame: Min. 3 years ]
    e.g. operated versus non-operated

  11. Balloon pulmonary angioplasty (BPA) [ Time Frame: Min. 3 years ]
    e.g. BPA versus pulmonary endarterectomy (PEA)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02656238

Hide Hide 38 study locations
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United States, California
UC San Diego
La Jolla, California, United States, 92037-7892
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
St Vincent's Hospital
Darlinghurst, Australia, NSW 2010
The Alfred Hospital
Prahran, Australia, 3181
University Clinics of Vienna
Vienna, Austria, 1090
University Hospitals of Leuven
Leuven, Belgium, 3000
University of Sao Paulo Medical School
Sao Paulo, Brazil, 05403900
Hospital São Paulo, Federal University of São Paulo
São Paulo, Brazil, 04023-062
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, ON M5G 2C4
Aarhus University Hospital
Aarhus, Denmark, 8200
Kasr Alaini School of Medicine
Cairo, Egypt, 12411
Helsinki University Hospital
Helsinki, Finland, 00250
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
University of Pavia
Pavia, Italy, 27100
Chiba University Hospital
Chiba, Japan, 260-8670
Kobe University Graduate School of Medicine
Kobe, Japan, 750-0017
National Hospital Organization Okayama
Okayama, Japan, 701-1192
Kyorin University Hospital
Tokyo, Japan, 181-8611
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
VU University Medical Center
Amsterdam, Netherlands, 1081
Europejskim Centrum Zdrowia Otwock
Otwock, Poland, 05-400
Medical University of Warsaw
Warsaw, Poland, 00-005
Wojewódzki Szpital Specjalistyczny
Wroclaw, Poland, 51-124
Russian Federation
Cardiology Research Center
Moscow, Russian Federation, 121552
Novosibirsk Research Institute of Circulation Pathology Academician E.N.Meshalkin
Novosibirsk, Russian Federation, 630055
Slovak Medical University and National Institute for Cardiovascular Diseases
Bratislava, Slovakia, 83348
Hospital Clinic Barcelona
Barcelona, Spain, 8036
Hospital Universitarion 12 Octubre
Madrid, Spain, 28041
UniversitätsSpital Zürich
Zürich, Switzerland, 8005
National Taiwan University Hospital
Taipei City, Taiwan, 10002
Marmara University School of Medicine
Istanbul, Turkey, 34899
United Kingdom
Papworth Hospital
Cambridge, United Kingdom, CB3 8RE
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Royal Free London NHS Foundation Trust
London, United Kingdom, MW3 2QG
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
International CTEPH Association
Additional Information:
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Responsible Party: International CTEPH Association Identifier: NCT02656238    
Other Study ID Numbers: CTEPH Registry
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Keywords provided by International CTEPH Association:
Balloon pulmonary angioplasty
Chronic thromboembolic pulmonary hypertension
Pulmonary endarterectomy
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases