Recruiting

Observational Study

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT03579862

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Draw

Study Details

Brief summary:

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 ID

NCT03579862

Start date

Dec 25, 2013

Status verified date

Oct, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

260 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Pulmonary Embolism (PE)

Pulmonary Arterial Hypertension (PAH)

Interventions

Blood Draw

Primary outcome measure

  • Rates of family history of VTE in relatives of CTEPH patients compared to PE and PAH patients in Intermountain populations [ Time Frame: through study completion, approximately 18 months ]

Central Contacts and Locations

Central contacts

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Principal Investigator:

Mark Dodson, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Oct 18, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2022-10-18.