Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)

NCT06105242 | Recruiting

• 1 other identifier: 1051738
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To identify biological sex differences in baseline RV function in CTEPH
2. 2.To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH
3. 3.To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

Conditions

CTEPH

Outcome Measures

Primary Outcomes (3)

• Biosphere

  To assess biological sex differences in baseline RV function in CTEPH

  1 year

• Biopshere

  To determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH

  1 year

• Biosphere

  To assess if and how sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

  1 year

Study Arms (3)

Retrospective Cohort Aim 1

Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol.

Retrospective Cohort Aim 2

Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol.

Prospective Cohort Aim 3

Aim 3 is prospective and will enroll a distinct set of patients from Aim 1 and 2.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with right ventricular failure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 27, 2023
• Study Start: May 30, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

US (1)