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

Sponsor
Intermountain Health Care, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT06105242
Collaborator
(none)
10
Enrollment
1
Location
55.1
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension
    Actual Study Start Date :
    May 30, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Biosphere [1 year]

      To assess biological sex differences in baseline RV function in CTEPH

    2. Biopshere [1 year]

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

    3. Biosphere [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Intermountain Medical Center Murray Utah United States 84107

    Sponsors and Collaborators

    • Intermountain Health Care, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Intermountain Health Care, Inc.
    ClinicalTrials.gov Identifier:
    NCT06105242
    Other Study ID Numbers:
    • 1051738
    First Posted:
    Oct 27, 2023
    Last Update Posted:
    Oct 27, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 27, 2023