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Completed

NCT Number: NCT02656238

New International CTEPH Database

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.

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Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension CTEPH

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Hospital, Darlinghurst, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Death

    Time frame: Min. 3 years

  2. Lung transplantation

    Time frame: Min. 3 years

  3. Change in New York Heart Association (NYHA) functional class

    Time frame: Min 3. years

Secondary outcomes

  1. Age at diagnosis

    Time frame: Min. 3 years

  2. Gender

    Time frame: Min. 3 years

  3. Ethnicity

    Time frame: Min. 3 years

  4. Disease severity

    Time frame: Min. 3 years

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

  5. History of deep vein thrombosis (DVT)

    Time frame: Min. 3 years

  6. History of acute pulmonary embolism

    Time frame: Min. 3 years

  7. Hemodynamic parameters

    Time frame: Min. 3 years

  8. Patient on oxygen (yes/no)

    Time frame: Min. 3 years

  9. Medical treatment

    Time frame: Min. 3 years

    e.g. mono- versus combination therapy

  10. Pulmonary endarterectomy (PEA)

    Time frame: Min. 3 years

    e.g. operated versus non-operated

  11. Balloon pulmonary angioplasty (BPA)

    Time frame: Min. 3 years

    e.g. BPA versus pulmonary endarterectomy (PEA)

Sponsors and collaborators

Lead sponsor

International CTEPH Association

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2016
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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