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

Recruiting

• Conditions: CTEPH

• Registration Number: NCT06105242
• Lead Sponsor: Intermountain Health Care, Inc.

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).

Study Timeline

• Study Start: 2022-05-30
• Study First Submitted: 2022-10-17
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States