New International CTEPH Database

Study Overview
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Brief Summary
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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.

Official Title
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New International CTEPH Database

Conditions
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Chronic Thromboembolic Pulmonary Hypertension, CTEPH

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | Min. 3 years | 
| Lung transplantation |  | Min. 3 years | 
| Change in New York Heart Association (NYHA) functional class |  | Min 3. years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTEPH, Balloon pulmonary angioplasty, Chronic thromboembolic pulmonary hypertension, Pulmonary endarterectomy, BPA, PEA