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

Intermountain Health Care, Inc.

Status: Enrolling

Conditions: CTEPH

Study type: Observational

Funder types: Other

Identifiers

NCT06105242

1051738

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

10 participants in 3 patient groups

Retrospective Cohort Aim 1

Description:

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

Description:

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

Description:

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