Loss of Y Chromosome in Aortic Stenosis

NCT ID: NCT06595407

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2026-06-01

Brief Summary

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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

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Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Males with aortic stenosis

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

Blood analysis for loss-of-Y chromosome

Intervention Type DIAGNOSTIC_TEST

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

Control males without aortic stenosis

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

Blood analysis for loss-of-Y chromosome

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood analysis for loss-of-Y chromosome

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Aortic stenosis (valve area \&lt;1.5cm2)

Exclusion Criteria

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

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Lindner, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan R Lindner, MD

Role: CONTACT

434 2979442

Bethany Gholson

Role: CONTACT

4342979444

Facility Contacts

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Jonathan Lindner

Role: primary

503-260-0672

Other Identifiers

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301597

Identifier Type: -

Identifier Source: org_study_id

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