Recruiting

NCT Number: NCT06595407

Loss of Y Chromosome in Aortic Stenosis

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Musculoskeletal Diseases Osteochondrodysplasias Ventricular Outflow Obstruction

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location status: Recruiting

Location contact

Jonathan Lindner

CONTACT

[email protected]

503-260-0672

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood analysis for loss-of-Y chromosome

Diagnostic Test

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

Primary outcomes

Loss of Y chromosome

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bethany Gholson

CONTACT

[email protected]

4342979444

Jonathan R Lindner, MD

CONTACT

[email protected]

434 2979442

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting