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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06105242
Enrollment
10
Registered
2023-10-27
Start date
2022-05-30
Completion date
2026-12-31
Last updated
2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CTEPH

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.

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).

Interventions

None listed

Sponsors

Intermountain Health Care, Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Biosphere1 yearTo assess biological sex differences in baseline RV function in CTEPH
Biopshere1 yearTo determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026