New International CTEPH Database

International CTEPH Association1,019 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,019

Conditions

Chronic Thromboembolic Pulmonary Hypertension CTEPH

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Death

Time frame: Min. 3 years

Lung transplantation

Time frame: Min. 3 years

Change in New York Heart Association (NYHA) functional class

Time frame: Min 3. years

Secondary Outcomes

Age at diagnosis

Time frame: Min. 3 years

Gender

Time frame: Min. 3 years

Ethnicity

Time frame: Min. 3 years

Disease severity

As measured by New York Heart Association (NYHA) functional class

Time frame: Min. 3 years

History of deep vein thrombosis (DVT)

Time frame: Min. 3 years

History of acute pulmonary embolism

Time frame: Min. 3 years

Hemodynamic parameters

Time frame: Min. 3 years

Patient on oxygen (yes/no)

Time frame: Min. 3 years

Medical treatment

e.g. mono- versus combination therapy

Time frame: Min. 3 years

Pulmonary endarterectomy (PEA)

e.g. operated versus non-operated

Time frame: Min. 3 years

Balloon pulmonary angioplasty (BPA)

e.g. BPA versus pulmonary endarterectomy (PEA)

Time frame: Min. 3 years