Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
Recruiting · NCT06105242 · Observational (researchers observe without assigning treatment) · Lead sponsor: Intermountain Health Care, Inc.
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Intermountain Medical Center - Murray, Utah, United States