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U.S. CTEPH Registry

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ClinicalTrials.gov Identifier: NCT02429284
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
E Squared Trials and Registries, Inc.
Information provided by (Responsible Party):
Kim Kerr, University of California, San Diego

Brief Summary:
The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of the Registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of patients with CTEPH through shared information, education, and collaborative investigation among pulmonary hypertension (PH) centers of excellence throughout the U.S.

Condition or disease
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pulmonary Hypertension

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Study Type : Observational [Patient Registry]
Actual Enrollment : 754 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: United States CTEPH Registry
Actual Study Start Date : April 2015
Actual Primary Completion Date : May 2019
Actual Study Completion Date : November 2019


Group/Cohort
Patients newly diagnosed with CTEPH
Patients newly diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension.



Primary Outcome Measures :
  1. Describe the patterns of evaluation of CTEPH Patients [ Time Frame: up to 5 years ]
  2. Describe the patters of risk factors and clinical presentation of CTEPH Patients [ Time Frame: up to 5 years ]
  3. Outcomes of medical and surgical therapy of CTEPH patients as assessed by hemodynamics, quality of life, and functional status [ Time Frame: up to 5 years, at 6 month intervals ]


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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
All consecutive consenting patients recently diagnosed (< 6 months) with CTEPH at participating study sites will be enrolled. Patients must meet inclusion criteria and have the diagnosis of CTEPH confirmed by the Adjudication Committee (AC) to be enrolled. Adult and pediatric patients may be enrolled and prior medical therapy will not exclude patients from enrollment.
Criteria

Inclusion Criteria:

  • Patients must be a permanent resident of the United States
  • Documentation of the following hemodynamic parameters by right heart catheterization

    • Mean pulmonary arterial pressure (PAPm) ≥ 25 mm Hg at rest and,
    • Pulmonary artery wedge pressure (PAWP) ≤ 15 mm Hg (or > 15 mmHg if justified)
  • Radiologic confirmation that chronic thromboembolic disease is the cause of the pulmonary hypertension by

    • One or more mismatched perfusion defect(s) by lung ventilation/perfusion scan, and
    • Confirmation of chronic thromboembolic disease by evidence of bands/webs, vessel narrowing or occlusion seen on CT pulmonary angiogram (CTA), conventional angiography or MR angiography (MRA).
  • Patients must be diagnosed with CTEPH within 6 months of being considered for study eligibility (signing of consent to participate). The date of diagnosis will be defined as when both hemodynamic criteria have been met and chronic thromboembolic disease is confirmed to be the cause of the pulmonary hypertension by an abnormal V/Q scan and the presence of chronic thromboembolic disease on CTA, MRA or pulmonary angiography. Hemodynamic and radiologic criteria can be met at separate time points; the most recently met criteria time point will be defined as the date of diagnosis.
  • Prior to enrollment all subjects must have the diagnosis of CTEPH confirmed by the Adjudication Committee.

Exclusion Criteria:

  • Patients unwilling or unable to provide written consent for participation in the study. Appropriate surrogate consent will be obtained for pediatric patients as defined by each investigational site's IRB.
  • Patients with an underlying medical disorder with an anticipated life expectancy less than 2 years.
  • Patients who do not meet inclusion criteria including:

    • Have not had documentation of hemodynamic criteria by right heart catheterization as outlined in the inclusion criteria
    • Do not have radiologic confirmation of chronic thromboembolic disease as outlined in the inclusion criteria
    • Meet the criteria for inclusion into WHO Groups I, II, III, or V

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): NCT02429284


Locations
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United States, California
UCSD Health System
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
E Squared Trials and Registries, Inc.
Investigators
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Principal Investigator: Kim M Kerr, MD University of California, San Diego
Additional Information:
Publications:
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Responsible Party: Kim Kerr, Clinical Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02429284    
Other Study ID Numbers: PH-2013-008
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Keywords provided by Kim Kerr, University of California, San Diego:
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Pulmonary Endarterectomy (PEA)
Pulmonary Thromboendarterectomy (PTE)
Pulmonary Hypertension
Balloon Pulmonary Angioplasty (BPA)
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases