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New International CTEPH Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02656238
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
International CTEPH Association

Study Description
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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.


Condition or disease
Chronic Thromboembolic Pulmonary Hypertension CTEPH

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1019 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: New International CTEPH Database
Study Start Date : February 2015
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients recently diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), meeting the registry's inclusion criteria, are eligible for inclusion into the New International CTEPH Database.

Only newly diagnosed, i.e. incident patients are eligible for inclusion. A patient is considered an incident patient if a diagnostic heart catheterization was performed within 1 year prior to the initial inclusion visit (for the first patient included) at the site participating in the New International CTEPH Database.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656238


Locations
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Sponsors and Collaborators
International CTEPH Association
More Information
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Additional Information:

Publications of Results:

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Responsible Party: International CTEPH Association
ClinicalTrials.gov Identifier: NCT02656238    
Other Study ID Numbers: CTEPH Registry
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022
Keywords provided by International CTEPH Association:
CTEPH
Balloon pulmonary angioplasty
Chronic thromboembolic pulmonary hypertension
 Pulmonary endarterectomy
BPA
PEA
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases