Loss of Y Chromosome in Aortic Stenosis

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06595407
Status
Recruiting
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Conditions

  • Aortic Stenosis

Eligibility Criteria

Sex
MALE
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Blood analysis for loss-of-Y chromosome — DIAGNOSTIC_TEST
    Analysis for the percentage of circulating leukocytes with loss-of-y chromosome

Study Details

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.

Key Dates

Start date
Aug 15, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Males with aortic stenosis
    Males with mild or greater aortic stenosis (aortic valve area \<1.5 cm2) due to calcific non-congenital aortic stenosis.
  • Arm: Control males without aortic stenosis
    Males without any diagnosis for aortic stenosis (matched for aortic stenosis group).

Primary Outcome Measure

Loss of Y chromosome [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Jonathan Lindner
[email protected]
503-260-0672

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By research site
University of Virginia· Charlottesville, VA

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