Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
Purpose
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.
Condition
- CTEPH
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
Intermountain Medical Center
Murray, Utah 84107
Murray, Utah 84107
More Details
- Status
- Recruiting
- Sponsor
- Intermountain Health Care, Inc.
Study Contact
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).