Valvular Heart DiseasePREVUE-VALVENCT05357404
Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE
An observational study of Valvular Heart Disease, run by Cardiovascular Research Foundation, New York at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Disease
- How many people
- 2,870 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Age 65-85
- Ability to provide informed consent
- Stably domiciled in a residence that can be accessed by study personnel
Who cannot join
- History of complex congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Keywords
- Valvular Heart Disease, Aortic Stenosis, Aortic Regurgitation, Mitral Regurgitation, Tricuspid Regurgitation, Epidemiology, Deep Learning, Electrocardiogram, Artificial intelligence, Biomarkers
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
Moderate or greater aortic stenosis (at baseline)
Measured: Baseline
Moderate or greater aortic regurgitation (at baseline)
Measured: Baseline
Moderate or greater mitral stenosis (at baseline)
Measured: Baseline
Moderate or greater mitral regurgitation (at baseline)
Measured: Baseline
Moderate or greater tricuspid regurgitation (at baseline)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start21 Apr 2022
- Primary completion31 Jan 2025
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research Foundation, New York
- Sponsor type
- University, hospital or other
- Collaborators
- CVS Caremark, Hawthorne Effect Inc., Columbia University, Vanderbilt University Medical Center, University of Michigan, Walgreens
- Responsible party
- Sponsor
- Investigators
- David J Cohen, MD, Principal investigator, CardioVascular Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357404
- Sponsor's protocol ID
- PREVUE VALVE
- Acronym
- PREVUE-VALVE
- Status last verified
- Feb 2025
- First submitted
- 24 Apr 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poterucha TJ, Hughes JW, Brener MI, Chuang ML, Hamid NB, Snyder C, Thompson J, Ungarten J, Takahashi K, Lindman BR, Roedan Oliver FA, Finer J, Hartzel D, Hartman H, Long A, Rocha D, Malta P, Castillo M, Ricart RP, Ruhl JA, vanMaanen D, Rogers AJ, Perez M, Tastet O, Avram R, Nishimura R, Granada JF, Mack MJ, Leon MB, Elias P, Cohen DJ; PREVUE-VALVE Study Investigators. AI-ECG Detection of Structural Heart Disease in the Community Setting: Transportability and Spectrum Effects in the PREVUE-VALVE Study. J Am Coll Cardiol. 2026 Aug 18;88(7):752-764. doi: 10.1016/j.jacc.2026.06.013.
PubMed 42615442Brener MI, Chuang ML, Nishimura R, Hamid NB, Snyder C, Thompson JB, Ungarten J, Takahashi K, Poterucha TJ, Elias P, Lindman BR, Shimbo D, Pocock SJ, Granada JF, Mack MJ, Leon MB, Cohen DJ. Population Prevalence of Valvular Heart Disease in the United States: The PREVUE-VALVE Study. J Am Coll Cardiol. 2026 Jun 16;87(23):3227-3239. doi: 10.1016/j.jacc.2026.02.5137.
PubMed 42300818
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE (PREVUE-VALVE)
- ClinicalTrials.gov ID
- NCT05357404
- Acronym / sponsor ID
- PREVUE-VALVE / PREVUE VALVE
- Conditions
- Valvular Heart Disease
- Keywords
- Valvular Heart Disease, Aortic Stenosis, Aortic Regurgitation, Mitral Regurgitation, Tricuspid Regurgitation, Epidemiology, Deep Learning, Electrocardiogram
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,870 participants (actual)
- Lead sponsor
- Cardiovascular Research Foundation, New YorkUniversity, hospital or other
- Collaborators
- CVS Caremark, Hawthorne Effect Inc., Columbia University, Vanderbilt University Medical Center, University of Michigan, Walgreens
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 65-85
- Ability to provide informed consent
- Stably domiciled in a residence that can be accessed by study personnel
Key exclusion criteria (1 listed)
- History of complex congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Valvular Heart Disease
Time frame: Baseline
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.
5 secondary outcomes
Moderate or greater aortic stenosis (at baseline)
Time frame: Baseline
Moderate or greater aortic regurgitation (at baseline)
Time frame: Baseline
Moderate or greater mitral stenosis (at baseline)
Time frame: Baseline
Moderate or greater mitral regurgitation (at baseline)
Time frame: Baseline
Moderate or greater tricuspid regurgitation (at baseline)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 42615442Poterucha TJ, Hughes JW, Brener MI, Chuang ML, Hamid NB, Snyder C, Thompson J, Ungarten J, Takahashi K, Lindman BR, Roedan Oliver FA, Finer J, Hartzel D, Hartman H, Long A, Rocha D, Malta P, Castillo M, Ricart RP, Ruhl JA, vanMaanen D, Rogers AJ, Perez M, Tastet O, Avram R, Nishimura R, Granada JF, Mack MJ, Leon MB, Elias P, Cohen DJ; PREVUE-VALVE Study Investigators. AI-ECG Detection of Structural Heart Disease in the Community Setting: Transportability and Spectrum Effects in the PREVUE-VALVE Study. J Am Coll Cardiol. 2026 Aug 18;88(7):752-764. doi: 10.1016/j.jacc.2026.06.013.
- Derived from this study: PubMed 42300818Brener MI, Chuang ML, Nishimura R, Hamid NB, Snyder C, Thompson JB, Ungarten J, Takahashi K, Poterucha TJ, Elias P, Lindman BR, Shimbo D, Pocock SJ, Granada JF, Mack MJ, Leon MB, Cohen DJ. Population Prevalence of Valvular Heart Disease in the United States: The PREVUE-VALVE Study. J Am Coll Cardiol. 2026 Jun 16;87(23):3227-3239. doi: 10.1016/j.jacc.2026.02.5137.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Cohen, MD principal investigator
CardioVascular Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease, run by Cardiovascular Research Foundation, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Valvular Heart Disease (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05357404, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.