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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02656238




Registration number
NCT02656238
Ethics application status
Date submitted
12/01/2016
Date registered
14/01/2016
Date last updated
8/08/2022

Titles & IDs
Public title
New International CTEPH Database
Scientific title
New International CTEPH Database
Secondary ID [1] 0 0
CTEPH Registry
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Thromboembolic Pulmonary Hypertension 0 0
CTEPH 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death
Timepoint [1] 0 0
Min. 3 years
Primary outcome [2] 0 0
Lung transplantation
Timepoint [2] 0 0
Min. 3 years
Primary outcome [3] 0 0
Change in New York Heart Association (NYHA) functional class
Timepoint [3] 0 0
Min 3. years
Secondary outcome [1] 0 0
Age at diagnosis
Timepoint [1] 0 0
Min. 3 years
Secondary outcome [2] 0 0
Gender
Timepoint [2] 0 0
Min. 3 years
Secondary outcome [3] 0 0
Ethnicity
Timepoint [3] 0 0
Min. 3 years
Secondary outcome [4] 0 0
Disease severity
Timepoint [4] 0 0
Min. 3 years
Secondary outcome [5] 0 0
History of deep vein thrombosis (DVT)
Timepoint [5] 0 0
Min. 3 years
Secondary outcome [6] 0 0
History of acute pulmonary embolism
Timepoint [6] 0 0
Min. 3 years
Secondary outcome [7] 0 0
Hemodynamic parameters
Timepoint [7] 0 0
Min. 3 years
Secondary outcome [8] 0 0
Patient on oxygen (yes/no)
Timepoint [8] 0 0
Min. 3 years
Secondary outcome [9] 0 0
Medical treatment
Timepoint [9] 0 0
Min. 3 years
Secondary outcome [10] 0 0
Pulmonary endarterectomy (PEA)
Timepoint [10] 0 0
Min. 3 years
Secondary outcome [11] 0 0
Balloon pulmonary angioplasty (BPA)
Timepoint [11] 0 0
Min. 3 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* None specified

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2020
Sample size
Target
Accrual to date
Final
1019
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
The Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Brazil
State/province [7] 0 0
São Paulo
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Denmark
State/province [9] 0 0
Aarhus
Country [10] 0 0
Egypt
State/province [10] 0 0
Cairo
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
Germany
State/province [12] 0 0
Bad Nauheim
Country [13] 0 0
Germany
State/province [13] 0 0
Hannover
Country [14] 0 0
Germany
State/province [14] 0 0
Homburg
Country [15] 0 0
Italy
State/province [15] 0 0
Pavia
Country [16] 0 0
Japan
State/province [16] 0 0
Chiba
Country [17] 0 0
Japan
State/province [17] 0 0
Kobe
Country [18] 0 0
Japan
State/province [18] 0 0
Okayama
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Netherlands
State/province [21] 0 0
Amsterdam
Country [22] 0 0
Poland
State/province [22] 0 0
Otwock
Country [23] 0 0
Poland
State/province [23] 0 0
Warsaw
Country [24] 0 0
Poland
State/province [24] 0 0
Wroclaw
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Moscow
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Novosibirsk
Country [27] 0 0
Slovakia
State/province [27] 0 0
Bratislava
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Switzerland
State/province [30] 0 0
Zürich
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taipei City
Country [32] 0 0
Turkey
State/province [32] 0 0
Istanbul
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Cambridge
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Glasgow
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
International CTEPH Association
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02656238
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02656238