NCT06105242Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 17 Oct 2022
- Start date
- 30 May 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Intermountain Health Care, Inc.
- NCT number
- NCT06105242
What you commit to
- Study type: Observational
- Planned participants: 10
- From 30 May 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Any subjects \<18 years of age
Other
- Unclear or mixed PH diagnosis as designated by an expert clinician at Intermountain PH center
- Patients diagnosed during pregnancy
- Patients without a TTE and RHC at time of diagnosis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Intermountain Medical Center Coordinator of this site? Confirm its status | Murray | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.