Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE

Valvular Heart Disease Clinical Trial

— PREVUE-VALVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357404
• Other study ID #: PREVUE VALVE
• Status: Recruiting
• Start date: April 21, 2022
• Est. completion date: April 2025

Study information

• Verified date: December 2023
• Source: Cardiovascular Research Foundation, New York
• Contact: Jena Ungarten
• Phone: 6465826599
• Email: jungarten[@]crf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2250
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Locations

Country	Name	City	State
United States	Hawthorne Effect	Lafayette	California

Sponsors (7)

Lead Sponsor	Collaborator
Cardiovascular Research Foundation, New York	Columbia University, CVS Caremark, Hawthorne Effect Inc., University of Michigan, Vanderbilt University Medical Center, Walgreens Co.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Moderate or greater aortic stenosis (at baseline)		Baseline
Secondary	Moderate or greater aortic regurgitation (at baseline)		Baseline
Secondary	Moderate or greater mitral stenosis (at baseline)		Baseline
Secondary	Moderate or greater mitral regurgitation (at baseline)		Baseline
Secondary	Moderate or greater tricuspid regurgitation (at baseline)		Baseline