Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE

NCT ID: NCT05357404

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2870 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-21
• Study Completion Date: 2025-04-30

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).

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.

Conditions

Valvular Heart Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CVS Caremark

INDUSTRY

Sponsor Role: collaborator

Hawthorne Effect Inc.

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Walgreens

INDUSTRY

Sponsor Role: collaborator

Cardiovascular Research Foundation, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

CardioVascular Research Foundation

Locations

Hawthorne Effect

Walnut Creek, California, United States

Countries

United States

Other Identifiers

PREVUE VALVE

Identifier Type: -

Identifier Source: org_study_id