NCT06105242 · Intermountain Health Care, Inc.
Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
What this study 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.
View original scientific description
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.
Primary outcome measures
Biosphere
Time frame: 1 year
To assess biological sex differences in baseline RV function in CTEPH
Biopshere
Time frame: 1 year
To determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH
Biosphere
Time frame: 1 year
To assess if and how sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Murray, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 27, 2023 · Source of record for eligibility and locations