Loss of Y Chromosome in Aortic Stenosis

University of Virginia

Status: Enrolling

Conditions: Aortic Stenosis

Treatments: Diagnostic Test: Blood analysis for loss-of-Y chromosome

Study type: Observational

Funder types: Other

Identifiers

NCT06595407

301597

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Males with aortic stenosis

Description:

Males with mild or greater aortic stenosis (aortic valve area \<1.5 cm2) due to calcific non-congenital aortic stenosis.

Treatment:

Diagnostic Test: Blood analysis for loss-of-Y chromosome

Control males without aortic stenosis

Description:

Males without any diagnosis for aortic stenosis (matched for aortic stenosis group).

Treatment:

Diagnostic Test: Blood analysis for loss-of-Y chromosome