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New International CTEPH Database

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ClinicalTrials.gov Identifier: NCT02656238
Recruitment Status : Active, not recruiting
First Posted : January 14, 2016
Last Update Posted : August 27, 2019
Sponsor:
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
Estimated Primary Completion Date : January 2020
Estimated 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)



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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.

Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02656238


  Hide Study Locations
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
Australia
St Vincent's Hospital
Darlinghurst, Australia, NSW 2010
The Alfred Hospital
Prahran, Australia, 3181
Austria
University Clinics of Vienna
Vienna, Austria, 1090
Belgium
University Hospitals of Leuven
Leuven, Belgium, 3000
Brazil
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
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8200
Egypt
Kasr Alaini School of Medicine
Cairo, Egypt, 12411
Finland
Helsinki University Hospital
Helsinki, Finland, 00250
Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
Italy
University of Pavia
Pavia, Italy, 27100
Japan
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
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081
Poland
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
Slovakia
Slovak Medical University and National Institute for Cardiovascular Diseases
Bratislava, Slovakia, 83348
Spain
Hospital Clinic Barcelona
Barcelona, Spain, 8036
Hospital Universitarion 12 Octubre
Madrid, Spain, 28041
Switzerland
UniversitätsSpital Zürich
Zürich, Switzerland, 8005
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 10002
Turkey
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
ClinicalTrials.gov Identifier: NCT02656238     History of Changes
Other Study ID Numbers: CTEPH Registry
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Keywords provided by International CTEPH Association:
CTEPH
Balloon pulmonary angioplasty
Chronic thromboembolic pulmonary hypertension
Pulmonary endarterectomy
BPA
PEA
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases