Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)

Study Overview
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Brief Summary
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To identify biological sex differences in baseline RV function in CTEPH To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

Detailed Description
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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).

Official Title
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Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension

Conditions
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CTEPH

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Cohort Aim 1<br>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<br>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<br>Aim 3 is prospective and will enroll a distinct set of patients from Aim 1 and 2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biosphere | To assess biological sex differences in baseline RV function in CTEPH | 1 year | 
| Biopshere | To determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH | 1 year | 
| Biosphere | To assess if and how sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE. | 1 year |