New International CTEPH Database

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

New International CTEPH Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656238
• Other study ID #: CTEPH Registry
• Status: Completed
• Start date: February 2015
• Est. completion date: January 2020

Study information

• Verified date: August 2022
• Source: International CTEPH Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1019
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• CTEPH
• Hypertension
• Hypertension, Pulmonary

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Darlinghurst
Australia	The Alfred Hospital	Prahran
Austria	University Clinics of Vienna	Vienna
Belgium	University Hospitals of Leuven	Leuven
Brazil	University of Sao Paulo Medical School	Sao Paulo
Brazil	Hospital São Paulo, Federal University of São Paulo	São Paulo
Canada	Toronto General Hospital	Toronto	Ontario
Denmark	Aarhus University Hospital	Aarhus
Egypt	Kasr Alaini School of Medicine	Cairo
Finland	Helsinki University Hospital	Helsinki
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum des Saarlandes	Homburg
Italy	University of Pavia	Pavia
Japan	Chiba University Hospital	Chiba
Japan	Kobe University Graduate School of Medicine	Kobe
Japan	National Hospital Organization Okayama	Okayama
Japan	Kyorin University Hospital	Tokyo
Korea, Republic of	Samsung Medical Center	Seoul
Netherlands	VU University Medical Center	Amsterdam
Poland	Europejskim Centrum Zdrowia Otwock	Otwock
Poland	Medical University of Warsaw	Warsaw
Poland	Wojewódzki Szpital Specjalistyczny	Wroclaw
Russian Federation	Cardiology Research Center	Moscow
Russian Federation	Novosibirsk Research Institute of Circulation Pathology Academician E.N.Meshalkin	Novosibirsk
Slovakia	Slovak Medical University and National Institute for Cardiovascular Diseases	Bratislava
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Universitarion 12 Octubre	Madrid
Switzerland	UniversitätsSpital Zürich	Zürich
Taiwan	National Taiwan University Hospital	Taipei City
Turkey	Marmara University School of Medicine	Istanbul
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Western Infirmary	Glasgow
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United States	University of Maryland	Baltimore	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
International CTEPH Association

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Denmark,  Egypt,  Finland,  Germany,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Slovakia,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

References & Publications (1)

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 str — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		Min. 3 years
Primary	Lung transplantation		Min. 3 years
Primary	Change in New York Heart Association (NYHA) functional class		Min 3. years
Secondary	Age at diagnosis		Min. 3 years
Secondary	Gender		Min. 3 years
Secondary	Ethnicity		Min. 3 years
Secondary	Disease severity	As measured by New York Heart Association (NYHA) functional class	Min. 3 years
Secondary	History of deep vein thrombosis (DVT)		Min. 3 years
Secondary	History of acute pulmonary embolism		Min. 3 years
Secondary	Hemodynamic parameters		Min. 3 years
Secondary	Patient on oxygen (yes/no)		Min. 3 years
Secondary	Medical treatment	e.g. mono- versus combination therapy	Min. 3 years
Secondary	Pulmonary endarterectomy (PEA)	e.g. operated versus non-operated	Min. 3 years
Secondary	Balloon pulmonary angioplasty (BPA)	e.g. BPA versus pulmonary endarterectomy (PEA)	Min. 3 years

External Links

•   Abstract on long-term outcomes presented at ERS 2021
•   Description of the registry on the website of the International CTEPH Association