Loss of Y Chromosome in Aortic Stenosis

Recruiting

• Conditions: Aortic Stenosis
• Interventions: Diagnostic Test: Blood analysis for loss-of-Y chromosome

• Registration Number: NCT06595407
• Lead Sponsor: University of Virginia

Brief Summary

The most common heart valve disease in humans is aortic stenosis which is a critical narrowing of the valve through which the heart has to pump blood to the rest of the body. This condition occurs in 2-3% of adults over 65 years of age and when it progresses to a severe stage leads to heart failure and need for valve replacement procedures (including surgery and catheter-based replacement). Aortic stenosis has a strong male predominance. The purpose of this study is to evaluate whether loss of Y-chromosome from circulating blood cells in males, which has been associated with TGF-beta-related fibrosis of other organs, is associated with the development of aortic stenosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Aortic stenosis (valve area <1.5cm2)

Exclusion Criteria

• Bicuspid aortic valve
• History of radiation to chest
• Inflammatory (autoimmune, rheumatologic) disease associated with aortic stenosis
• Active cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Males with aortic stenosis	Blood analysis for loss-of-Y chromosome	Males with mild or greater aortic stenosis (aortic valve area \<1.5 cm2) due to calcific non-congenital aortic stenosis.
Control males without aortic stenosis	Blood analysis for loss-of-Y chromosome	Males without any diagnosis for aortic stenosis (matched for aortic stenosis group).

Primary Outcome Measures

Name	Time	Method
Loss of Y chromosome	1 day	This is a cross-sectional case-control study where the outcome measure is the percentage of circulating cells that have loss-of-Y chromosome

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States