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

October 23, 2023 updated by: Intermountain Health Care, Inc.

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

  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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meghan Cirulis, MD
        • Sub-Investigator:
          • Mark Dodson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with right ventricular failure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intermountain Health Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1051738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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