Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
ConditionCTEPH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIntermountain Health Care, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants with right ventricular failure
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10 Participants
are grouped into 3 trial groupsGroup A: Retrospective Cohort Aim 1
Group B: Retrospective Cohort Aim 2
Group C: Prospective Cohort Aim 3
Trial outcomes
Primary outcomes
1
Biosphere
To assess biological sex differences in baseline RV function in CTEPH
Time frame
1 year2
Biopshere
To determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH
Time frame
1 year3
Biosphere
To assess if and how sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov