Examining how biological sex affects heart function in CTEPH patients
Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension
This study looks at how being male or female affects heart function in people with chronic thromboembolic pulmonary hypertension (CTEPH) to see if there are any differences in their recovery after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Intermountain Health Care, Inc. Academic / other |
| Locations | 1 site (Murray, Utah) |
| Trial ID | NCT06105242 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify differences in right ventricular (RV) function between biological sexes in patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH). It will analyze historical data from patients who have undergone right heart catheterization and echocardiography to assess RV function at diagnosis and after pulmonary thromboendarterectomy (PTE) surgery. The study will also explore the relationship between sex hormone levels and RV function during diagnosis and recovery. The methodology includes TTE strain analysis to compare RV function across sexes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with CTEPH who have undergone the necessary diagnostic procedures.
Not a fit: Patients with unclear or mixed pulmonary hypertension diagnoses, those under 18, or pregnant individuals may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for CTEPH based on biological sex differences.
How similar studies have performed: While studies examining sex differences in cardiovascular conditions exist, this specific focus on CTEPH and RV function recovery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Murray, Utah
- Intermountain Medical Center — Murray, Utah, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.