Identification of Heritable CTEPH
Some patients who have blood clots come down with a life-threatening condition known as Chronic Thromboembolic Pulmonary Hypertension (CTEPH), which is high blood pressure only in the arteries of the lungs. This study seeks to understand more about the genetics causes of CTEPH by obtaining blood samples and examining family histories.
Conditions:
🦠 Chronic Thromboembolic Pulmonary Hypertension
🗓️ Study Start (Actual) 25 December 2013
🗓️ Primary Completion (Estimated) 31 December 2023
✅ Study Completion (Estimated) 31 December 2023
👥 Enrollment (Estimated) 260
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Murray, Utah, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * CTEPH cohort:
    • 1. Confirmed CTEPH based on having undergone PEA surgery.
    • 2. Strongly suspected CTEPH based on right heart catheterization data showing mPAP\>26 and PCWP\<15, and imaging demonstrating chronic thromboembolic disease (either ventilation/perfusion scan, CT pulmonary angiography, or conventional pulmonary angiography).
    • * PE cohort:
    • 1. PE diagnosed by CT pulmonary angiography or ventilation/perfusion scan within the preceding 24 months.
    • 2. No evidence of PH at the time of enrollment (based on absence of dyspnea, exertional chest pain, or exertional presyncope on history, lack of physical exam findings of PH or right heart failure, and lack of signs of PH on objective data including echocardiography and/or right heart catheterization).
    • 3. No evidence of chronic thromboembolic disease at the time of enrollment (based on chronic appearing thrombus on CT pulmonary angiography or conventional pulmonary angiography, or based on prior high probability ventilation/perfusion scan showing a similar pattern of perfusion defects).
    • * PAH cohort:
    • 1. Diagnosis of group 1 PAH.
    • 2. Prior normal or low probability ventilation/perfusion scan.
    • 3. No reported history of prior VTE events.
    • 4. If available, all prior evaluations for VTE (including CT pulmonary angiography and Doppler ultrasound exams) must also be negative.

    Exclusion Criteria:

    • * Under the age of 18
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 May 2018
  • First Submitted that Met QC Criteria 5 July 2018
  • First Posted 9 July 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 October 2022
  • Last Update Posted 18 October 2022
  • Last Verified October 2022