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

CTEPH Clinical Trial

Official title:

Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105242
• Other study ID #: 1051738
• Status: Recruiting
• Start date: May 30, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

Aims 1 and 2 together comprise a retrospective cohort study. We will identify historical subjects with newly diagnosed CTEPH using a clinical database. We will perform TTE strain analysis (RVGLS) to compare RV function between the biologic sexes at diagnosis and after surgical correction of CTEPH (to assess recovery).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CTEPH

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biosphere	To assess biological sex differences in baseline RV function in CTEPH	1 year
Primary	Biopshere	To determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH	1 year
Primary	Biosphere	To assess if and how sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.	1 year