U.S. CTEPH Registry

Trial ID or NCT#

NCT02429284

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

United States CTEPH Registry

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Roham Zamanian
Roham Zamanian
Pulmonary hypertension specialist, Pulmonologist, Critical care specialist
Professor of Medicine (Pulmonary and Critical Care Medicine)
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View on ClinicalTrials.gov