Clinical trial NCT02656238: New International CTEPH Database
Official title: New International CTEPH Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Thromboembolic Pulmonary Hypertension
CTEPH
Keywords: CTEPH
Balloon pulmonary angioplasty
Chronic thromboembolic pulmonary hypertension
Pulmonary endarterectomy
BPA
PEA
Lead sponsor: International CTEPH Association
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 1019
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Death
timeFrame: Min. 3 years
measure: Lung transplantation
timeFrame: Min. 3 years
measure: Change in New York Heart Association (NYHA) functional class
timeFrame: Min 3. years
Secondary outcomes:
measure: Age at diagnosis
timeFrame: Min. 3 years
measure: Gender
timeFrame: Min. 3 years
measure: Ethnicity
timeFrame: Min. 3 years
measure: Disease severity
timeFrame: Min. 3 years
measure: History of deep vein thrombosis (DVT)
timeFrame: Min. 3 years
measure: History of acute pulmonary embolism
timeFrame: Min. 3 years
measure: Hemodynamic parameters
timeFrame: Min. 3 years
measure: Patient on oxygen (yes/no)
timeFrame: Min. 3 years
measure: Medical treatment
timeFrame: Min. 3 years
measure: Pulmonary endarterectomy (PEA)
timeFrame: Min. 3 years
measure: Balloon pulmonary angioplasty (BPA)
timeFrame: Min. 3 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
city: Prahran
country: Australia
facility: The Alfred Hospital
city: Vienna
country: Austria
facility: University Clinics of Vienna
city: Leuven
country: Belgium
facility: University Hospitals of Leuven
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo Medical School
city: São Paulo
country: Brazil
facility: Hospital São Paulo, Federal University of São Paulo
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Cairo
country: Egypt
facility: Kasr Alaini School of Medicine
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Pavia
country: Italy
facility: University of Pavia
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine
city: Okayama
country: Japan
facility: National Hospital Organization Okayama
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Otwock
country: Poland
facility: Europejskim Centrum Zdrowia Otwock
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Wroclaw
country: Poland
facility: Wojewódzki Szpital Specjalistyczny
city: Moscow
country: Russian Federation
facility: Cardiology Research Center
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Circulation Pathology Academician E.N.Meshalkin
city: Bratislava
country: Slovakia
facility: Slovak Medical University and National Institute for Cardiovascular Diseases
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Madrid
country: Spain
facility: Hospital Universitarion 12 Octubre
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
References:
citation: 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.