Actively Recruiting
Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension
Led by Intermountain Health Care, Inc. · Updated on 2023-10-27
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying chronic thromboembolic pulmonary hypertension (CTEPH) to understand differences between biological sexes in how the right ventricle (RV) of the heart functions at diagnosis and recovers after surgery. The study aims to explore if sex hormone levels are related to RV function during diagnosis and recovery. This research includes both retrospective and prospective parts to gather comprehensive data on these aspects. The study includes a retrospective cohort analyzing historical patient data to assess RV function at diagnosis and after pulmonary thromboendarterectomy (PTE) surgery using echocardiogram strain analysis. Separately, a prospective cohort will enroll new patients to examine how sex hormone levels relate to RV function over time. The retrospective parts use past clinical databases, while the prospective part involves enrolling distinct patients and monitoring them. Participants provide clinical data including echocardiograms and right heart catheterization results at diagnosis and follow-up after surgery. Researchers will analyze heart function measures and hormone levels. The main outcomes focus on RV function patterns over one year. The study involves reviewing past records as well as collecting new clinical information, with no experimental treatments given. Participation duration varies depending on cohort involvement.
CONDITIONS
Brief Title
Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (≥18 years old) patients diagnosed with CTEPH per current guideline standard
- Must have a baseline echocardiogram (TTE) within 3 months of diagnosis with adequate images for RVGLS analysis
- Must have a right heart catheterization (RHC) at the time of diagnosis
- For Aim 2 analysis, patients must undergo pulmonary thromboendarterectomy (PTE) surgery and have a TTE 3-9 months after surgery with adequate images for RVGLS analysis
You will not qualify if you...
- Unclear or mixed pulmonary hypertension diagnosis as determined by an expert clinician
- Patients younger than 18 years
- Patients diagnosed during pregnancy
- Patients without both TTE and RHC at time of diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 3 months of diagnosis
Participants undergo baseline echocardiogram (TTE) and right heart catheterization (RHC) to assess right ventricular function at diagnosis of CTEPH.
1 visit (in-person)
Duration - Surgery and immediate recovery period
Participants undergo pulmonary thromboendarterectomy (PTE) surgery to correct CTEPH.
Duration - 3 to 9 months after surgery
Participants have a follow-up echocardiogram (TTE) 3 to 9 months after surgery to assess right ventricular recovery.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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