Clinical trial NCT05357404: Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE
Official title: Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE (PREVUE-VALVE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Valvular Heart Disease
Keywords: Valvular Heart Disease
Aortic Stenosis
Aortic Regurgitation
Mitral Regurgitation
Tricuspid Regurgitation
Epidemiology
Deep Learning
Electrocardiogram
Artificial intelligence
Biomarkers
Lead sponsor: Cardiovascular Research Foundation, New York
Sponsor class: OTHER
Collaborators: name: CVS Caremark
name: Hawthorne Effect Inc.
name: Columbia University
name: Vanderbilt University Medical Center
name: University of Michigan
name: Walgreens
First posted: 2022-05-02
Enrollment: 2870
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Prevalence of Valvular Heart Disease
timeFrame: Baseline
Secondary outcomes:
measure: Moderate or greater aortic stenosis (at baseline)
timeFrame: Baseline
measure: Moderate or greater aortic regurgitation (at baseline)
timeFrame: Baseline
measure: Moderate or greater mitral stenosis (at baseline)
timeFrame: Baseline
measure: Moderate or greater mitral regurgitation (at baseline)
timeFrame: Baseline
measure: Moderate or greater tricuspid regurgitation (at baseline)
timeFrame: Baseline
Other outcomes:
measure: Descriptive Statistics
timeFrame: Baseline
Locations:
city: Walnut Creek
country: United States
facility: Hawthorne Effect
state: California
Study officials:
affiliation: CardioVascular Research Foundation
name: David J Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: