Recruiting

Observational Study

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT06105242

Conditions

CTEPH

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

1. To identify biological sex differences in baseline RV function in CTEPH
2. To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH
3. To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

Conditions

CTEPH

Study ID

NCT06105242

Start date

May 30, 2022

Status verified date

Oct, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria

  • Adult (≥18 years old) patients diagnosed with CTEPH per current guideline standard42
  • Subject must have a baseline TTE (within 3 months of diagnosis) with adequate images for RVGLS analysis
  • Subject must have a right heart catheterization (RHC) at the time of diagnosis
  • To be included in the Aim 2 analysis, patients must undergo PTE surgery and have a TTE performed 3-9 months after surgery with adequate images for RVGLS strain analysis

Exclusion criteria

  • Unclear or mixed PH diagnosis as designated by an expert clinician at Intermountain PH center
  • Any subjects <18 years of age
  • Patients diagnosed during pregnancy
  • Patients without a TTE and RHC at time of diagnosis

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective Cohort Aim 1

Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol.

Retrospective Cohort Aim 2

Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol.

Prospective Cohort Aim 3

Aim 3 is prospective and will enroll a distinct set of patients from Aim 1 and 2.

Primary outcome measure

  • Biosphere [ Time Frame: 1 year ]
  • Biopshere [ Time Frame: 1 year ]
  • Biosphere [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Valerie Aston

801-507-4606valerie.aston@imail.org

Darrin Applegate

801-507-4814darrin.applegate@imail.org

Principal Investigator:

Meghan Cirulis, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Oct 27, 2023

Last verified

Oct, 2023

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 2023-10-27.