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

Last updated: October 23, 2023
Sponsor: Intermountain Health Care, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06105242
1051738
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 10
Study Start date:
May 30, 2022
Estimated Completion Date:
December 31, 2026

Study 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).

Connect with a study center

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Active - Recruiting

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