NCT06105242Recruiting
Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
Intermountain Health Care, Inc.
Start Date
5/30/2022
Completion Date
12/31/2026
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.
Detailed Description
Aims 1 and 2 together comprise a retrospective cohort study. We will identify historical subjects with newly diagnosed CTEPH using a clinical database. We will perform TTE strain analysis (RVGLS) to compare RV function between the biologic sexes at diagnosis and after surgical correction of CTEPH (to assess recovery).
Eligibility Criteria
Age Range: 18 years to No maximum
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
Conditions
CTEPH
Locations
Intermountain Medical Center
Murray, Utah 84107
United States