NCT06105242 Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
| NCT ID | NCT06105242 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Intermountain Health Care, Inc. |
| Condition | CTEPH |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-05-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2022-05-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06105242 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CTEPH. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105242 currently recruiting?
Yes, NCT06105242 is actively recruiting participants. Visit ClinicalTrials.gov or contact Intermountain Health Care, Inc. to inquire about joining.
Where is the NCT06105242 trial being conducted?
This trial is being conducted at Murray, United States.
Who is sponsoring the NCT06105242 clinical trial?
NCT06105242 is sponsored by Intermountain Health Care, Inc.. The trial plans to enroll 10 participants.