Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE (PREVUE-VALVE)

Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE (PREVUE-VALVE)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Valvular Heart Disease

Detailed Description

With the aging population, the incidence and prevalence of VHD are increasing in the U.S. and other parts of the developed world. Despite the availability of effective therapies and procedures to treat VHD, many patients remain (1) untreated due to undiagnosed VHD, or inadequate access to appropriate VHD care or (2) treated later than recommended due to diagnosis late in the disease course or barriers to prompt care for VHD. To optimize care for patients with VHD, it is therefore essential to (1) know the true prevalence of these conditions in order to align screening efforts with access to treatment; and (2) develop validated tools to more effectively screen and diagnose patients with VHD.

In response to these unmet needs, the PREVUE-VALVE study will establish reliable, population-based estimates of VHD prevalence in the United States and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of VHD. The results of this study will enable the investigators to make tangible progress toward the goal of treating all patients with VHD at the optimal time.

The study will be conducted in a sample of older individuals (i.e., age 65-85 years) that is representative of the U.S. population. The sample will be carefully curated to ensure traditionally underrepresented individuals are included and overrepresented, if possible. After obtaining informed consent, each participant will undergo a standard echocardiogram in order to identify VHD (specifically aortic, mitral, and tricuspid valve disease) and to quantify its severity using state-of-the-art methods in a core echocardiography laboratory. Echocardiograms will be performed in participants' homes in an effort to reduce any barriers towards participation. A variety of complementary data (i.e. blood sample, electrocardiograms, and clinical inventory including a standardized health status assessment) will be collected while study personnel are with participants. Formal statistical weighting methods will be applied to estimate the population prevalence of various subtypes of VHD (e.g., aortic stenosis, mitral regurgitation) from the raw data. In addition, the investigators will report the prevalence of VHD, including VHD subtypes, and describe the association between different blood analytes and ECG characteristics with VHD.

• Study Type: Observational
• Enrollment (Actual): 2870

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94596
      • Hawthorne Effect

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• History of complex congenital heart disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive Statistics	In addition to determining the population prevalence of each type of VHD at baseline, separate analyses will be performed to examine the cross-sectional relationship between age, sex, race, and ethnicity and the prevalence of valvular disease and its individual subtypes. The study will also evaluate the diagnostic performance of a machine learning model trained using 12-lead electrocardiograms to detect the primary endpoint and its components. Finally, the correlation between various blood analytes and significant valvular heart disease will also be assessed (specific analyses to be determined). In the future, long-term follow-up may be performed via linkage with health care claims data for patients who consent to this process.	Baseline

Collaborators and Investigators

• Sponsor: Cardiovascular Research Foundation, New York
• Collaborators: Columbia University; University of Michigan; Vanderbilt University Medical Center; CVS Caremark; Hawthorne Effect Inc.; Walgreens
• Investigators: Principal Investigator: David J Cohen, MD, CardioVascular Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Epidemiology; Aortic Stenosis; Biomarkers; Artificial intelligence; Mitral Regurgitation; Electrocardiogram; Deep Learning; Valvular Heart Disease; Aortic Regurgitation; Tricuspid Regurgitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: PREVUE VALVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No