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NCT Number: NCT06105242

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

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.

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Key information

Conditions

CTEPH

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Biosphere

    Time frame: 1 year

    To assess biological sex differences in baseline RV function in CTEPH

  2. Biopshere

    Time frame: 1 year

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

  3. 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.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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