Status:
RECRUITING
Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
Lead Sponsor:
Intermountain Health Care, Inc.
Conditions:
CTEPH
Eligibility:
All Genders
18+ years
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 hormon...
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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06105242
Start Date
May 30 2022
End Date
December 31 2026
Last Update
October 27 2023
Active Locations (1)
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1
Intermountain Medical Center
Murray, Utah, United States, 84107