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Loss of Y Chromosome in Aortic Stenosis

Loss of Y Chromosome in Aortic Stenosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06595407
Enrollment
200
Registered
2024-09-19
Start date
2024-08-15
Completion date
2026-06-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Aortic stenosis, Y-chromosome, Transforming growth factor-beta, Echocardiography

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.

Interventions

DIAGNOSTIC_TESTBlood analysis for loss-of-Y chromosome

Analysis for the percentage of circulating leukocytes with loss-of-y chromosome

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Loss of Y chromosome1 dayThis is a cross-sectional case-control study where the outcome measure is the percentage of circulating cells that have loss-of-Y chromosome

Countries

United States

Contacts

Primary ContactJonathan R Lindner, MD
jlindner@virginia.edu434 2979442
Backup ContactBethany Gholson
bethany.gholson@uvahealth.org4342979444

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026