New International CTEPH Database
- Conditions
- Chronic Thromboembolic Pulmonary HypertensionCTEPH
- Registration Number
- NCT02656238
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1019
-
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
- None specified
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lung transplantation Min. 3 years Change in New York Heart Association (NYHA) functional class Min 3. years Death Min. 3 years
- Secondary Outcome Measures
Name Time Method History of deep vein thrombosis (DVT) Min. 3 years Age at diagnosis Min. 3 years Gender Min. 3 years Patient on oxygen (yes/no) Min. 3 years Medical treatment Min. 3 years e.g. mono- versus combination therapy
Pulmonary endarterectomy (PEA) Min. 3 years e.g. operated versus non-operated
Balloon pulmonary angioplasty (BPA) Min. 3 years e.g. BPA versus pulmonary endarterectomy (PEA)
Ethnicity Min. 3 years Disease severity Min. 3 years As measured by New York Heart Association (NYHA) functional class
History of acute pulmonary embolism Min. 3 years Hemodynamic parameters Min. 3 years
Trial Locations
- Locations (38)
University Hospitals of Leuven
🇧🇪Leuven, Belgium
Aarhus University Hospital
🇩🇰Aarhus, Denmark
St Vincent's Hospital
🇦🇺Darlinghurst, Australia
University of Maryland
🇺🇸Baltimore, Maryland, United States
UC San Diego
🇺🇸La Jolla, California, United States
Wojewódzki Szpital Specjalistyczny
🇵🇱Wroclaw, Poland
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Novosibirsk Research Institute of Circulation Pathology Academician E.N.Meshalkin
🇷🇺Novosibirsk, Russian Federation
Hospital Universitarion 12 Octubre
🇪🇸Madrid, Spain
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
VU University Medical Center
🇳🇱Amsterdam, Netherlands
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
Kobe University Graduate School of Medicine
🇯🇵Kobe, Japan
Europejskim Centrum Zdrowia Otwock
🇵🇱Otwock, Poland
Marmara University School of Medicine
🇹🇷Istanbul, Turkey
Kyorin University Hospital
🇯🇵Tokyo, Japan
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Chiba University Hospital
🇯🇵Chiba, Japan
National Hospital Organization Okayama
🇯🇵Okayama, Japan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
University of Sao Paulo Medical School
🇧🇷Sao Paulo, Brazil
Kerckhoff-Klinik GmbH
🇩🇪Bad Nauheim, Germany
Helsinki University Hospital
🇫🇮Helsinki, Finland
Medical University of Warsaw
🇵🇱Warsaw, Poland
UniversitätsSpital Zürich
🇨🇭Zürich, Switzerland
University of Pavia
🇮🇹Pavia, Italy
Western Infirmary
🇬🇧Glasgow, United Kingdom
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Kasr Alaini School of Medicine
🇪🇬Cairo, Egypt
The Alfred Hospital
🇦🇺Prahran, Australia
University Clinics of Vienna
🇦🇹Vienna, Austria
Hospital São Paulo, Federal University of São Paulo
🇧🇷São Paulo, Brazil
Cardiology Research Center
🇷🇺Moscow, Russian Federation
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Slovak Medical University and National Institute for Cardiovascular Diseases
🇸🇰Bratislava, Slovakia
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom