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

Intermountain Health Care, Inc.10 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

CTEPH

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Intermountain Medical Center

Murray, Utah, United States

RECRUITING

Outcomes

Primary Outcomes

Biosphere

To assess biological sex differences in baseline RV function in CTEPH

Time frame: 1 year

Biopshere

To determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH

Time frame: 1 year

Biosphere

To assess if and how sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

Time frame: 1 year

Data from ClinicalTrials.gov

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