New International CTEPH Database

Completed

• Conditions: Chronic Thromboembolic Pulmonary Hypertension; CTEPH

• 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

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-14
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1019

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in New York Heart Association (NYHA) functional class	Min 3. years
Death	Min. 3 years
Lung transplantation	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)

UC San Diego; 🇺🇸 La Jolla, California, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

St Vincent's Hospital; 🇦🇺 Darlinghurst, Australia

The Alfred Hospital; 🇦🇺 Prahran, Australia

University Clinics of Vienna; 🇦🇹 Vienna, Austria

University Hospitals of Leuven; 🇧🇪 Leuven, Belgium

University of Sao Paulo Medical School; 🇧🇷 Sao Paulo, Brazil

Hospital São Paulo, Federal University of São Paulo; 🇧🇷 São Paulo, Brazil

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

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