Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE

NCT05357404 | Active Not Recruiting

• 1 other identifier: PREVUE VALVE
• Study Type: observational
• Target: 2,870
• Locations: 1 country
• Sites: 1

Brief Summary

The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of Valvular Heart Disease (VHD).

Conditions

Valvular Heart Disease

Keywords

Valvular Heart Disease; Aortic Stenosis; Aortic Regurgitation; Mitral Regurgitation; Tricuspid Regurgitation; Epidemiology; Deep Learning; Electrocardiogram; Artificial intelligence; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Prevalence of Valvular Heart Disease

  The primary endpoint of the study is the presence of any significant (i.e. moderate or greater) valvular heart disease at the baseline assessment including aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation, or tricuspid regurgitation.

  Baseline

Secondary Outcomes (5)

• Moderate or greater aortic stenosis (at baseline)

  Baseline

• Moderate or greater aortic regurgitation (at baseline)

  Baseline

• Moderate or greater mitral stenosis (at baseline)

  Baseline

• Moderate or greater mitral regurgitation (at baseline)

  Baseline

• Moderate or greater tricuspid regurgitation (at baseline)

  Baseline

Other Outcomes (1)

• Descriptive Statistics

  Baseline

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults aged 65-85 will be eligible to participate. Population sampling techniques will be used to ensure that the study population is broadly representative of the age, sex, and racial distribution of the United States.

You may qualify if:

• Age 65-85
• Ability to provide informed consent
• Stably domiciled in a residence that can be accessed by study personnel

You may not qualify if:

• History of complex congenital heart disease

Sponsors & Collaborators

• Cardiovascular Research Foundation, New York: lead
• CVS Caremark: collaborator
• Hawthorne Effect Inc.: collaborator
• Columbia University: collaborator
• Vanderbilt University Medical Center: collaborator
• University of Michigan: collaborator
• Walgreens: collaborator

Study Sites (1)

Hawthorne Effect

Walnut Creek, California, 94596, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Study participants will have the option to undergo in-home phlebotomy in order to create a biospecimen repository ("biobank"). Blood samples will be collected during the home visit, and overnight mailed to the biobank core lab. Once they arrive at the biobank core lab, samples will be immediately processed, aliquoted, and frozen for future analyses.

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Study Officials

• David J Cohen, MD

  CardioVascular Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 2, 2022
• Study Start: April 21, 2022
• Primary Completion: January 31, 2025
• Study Completion: April 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)