Aortic StenosisNCT06595407
Loss of Y Chromosome in Aortic Stenosis
An observational study of Aortic Stenosis, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Blood analysis for loss-of-Y chromosome
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males with calcific, non-congenital aortic stenosis and age-matched males without aortic stenosis.
Who may be able to join
- Aortic stenosis (valve area \<1.5cm2)
Who cannot join
- Bicuspid aortic valve
- History of radiation to chest
- Inflammatory (autoimmune, rheumatologic) disease associated with aortic stenosis
- Active cancer
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Jonathan Lindner, 503-260-0672, jlindner@virginia.edu
About this study
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.
- Conditions
- Aortic Stenosis
- Being tested
- Blood analysis for loss-of-Y chromosome
- Keywords
- Aortic stenosis, Y-chromosome, Transforming growth factor-beta, Echocardiography
- Medical subject headings
- Aortic Valve Stenosis, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood analysis for loss-of-Y chromosomeDiagnostic test
Analysis for the percentage of circulating leukocytes with loss-of-y chromosome
| Study group | Role | What they receive |
|---|---|---|
| Males with aortic stenosis | Males with mild or greater aortic stenosis (aortic valve area <1.5 cm2) due to calcific non-congenital aortic stenosis. Receives: Diagnostic Test: Blood analysis for loss-of-Y chromosome | |
| Control males without aortic stenosis | Males without any diagnosis for aortic stenosis (matched for aortic stenosis group). Receives: Diagnostic Test: Blood analysis for loss-of-Y chromosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of Y chromosome
This is a cross-sectional case-control study where the outcome measure is the percentage of circulating cells that have loss-of-Y chromosome
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Aug 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Lindner, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595407
- Sponsor's protocol ID
- 301597
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated during the course of this research will be made available in accordance with the Final NIH Statement of Sharing Research Data, Notice: NOT-OD-03-032. Data will be shared on the common data elements (CDE) system from the NIH CDE Repository.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loss of Y Chromosome in Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06595407
- Acronym / sponsor ID
- 301597
- Conditions
- Aortic Stenosis
- Keywords
- Aortic stenosis, Y-chromosome, Transforming growth factor-beta, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males with aortic stenosis | – | Diagnostic Test: Blood analysis for loss-of-Y chromosomeMales with mild or greater aortic stenosis (aortic valve area <1.5 cm2) due to calcific non-congenital aortic stenosis. |
| Control males without aortic stenosis | – | Diagnostic Test: Blood analysis for loss-of-Y chromosomeMales without any diagnosis for aortic stenosis (matched for aortic stenosis group). |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males with calcific, non-congenital aortic stenosis and age-matched males without aortic stenosis.
Key inclusion criteria (1 listed)
- Aortic stenosis (valve area \<1.5cm2)
Key exclusion criteria (4 listed)
- Bicuspid aortic valve
- History of radiation to chest
- Inflammatory (autoimmune, rheumatologic) disease associated with aortic stenosis
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood analysis for loss-of-Y chromosomeAnalysis for the percentage of circulating leukocytes with loss-of-y chromosome | Diagnostic test | Control males without aortic stenosis, Males with aortic stenosis |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. All data generated during the course of this research will be made available in accordance with the Final NIH Statement of Sharing Research Data, Notice: NOT-OD-03-032. Data will be shared on the common data elements (CDE) system from the NIH CDE Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan R Lindner, MD (434 2979442, jlindner@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of Y chromosome (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.