Valvular Heart DiseaseNCT05453526
The Bronx-Valve Registry
An observational study of Valvular Heart Disease, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams. Valvular heart disease (VHD) is a major focus of cardiovascular medicine, but limited data are available for racial and ethnic minorities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- How many people
- 330,570 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2010to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients undergoing echocardiographic assessment at Montefiore Medical Center (Bronx, NY, USA) will be included in this registry.
Who may be able to join
- Minimum age of 18 years old
- Undergoing transthoracic or transesophageal echocardiographic assessment at Montefiore Medical Center or affiliated institutions in the Bronx (NY, USA)
Who cannot join
- Age below 18 years old
- No available information regarding race or ethnicity
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Burden of Valvular Heart Diseases in an Ethnical/Racial Diverse Background of the United States: the Bronx-Valve Registry
The Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams. Valvular heart disease (VHD) is a major focus of cardiovascular medicine, but limited data are available for racial and ethnic minorities. The aim was to assess the burden and clinical correlates of VHD in a highly diverse area of the United States.
Read the detailed description
Cardiovascular disease is the leading cause of death in the general US population. Although the burden of valvular heart disease is increasing due to a rapidly aging population, patients can benefit from improved and more accessible imaging modalities, and novel minimally invasive treatments. However, medical knowledge and technological developments might not be generalizable to all patient backgrounds due to lack of diversity in scientific literature.
Historically, clinical trials testing new treatment modalities have lacked equitable inclusion of people coming from racial/ethnic minority groups. Similarly, epidemiological studies have focused on specific patient subsets with no direct comparisons with the other backgrounds. The Bronx county (New York, USA) is considered by the US Census as the most diverse area in the country, having the highest overwhelming concentration of non-white populations and being the only borough in all of New York City to be almost exclusively populated by non-white enclaves. These demographic characteristics make this county ideal to assess how the prevalence and the clinical correlates of valvular heart diseases might vary among diverse populations.
On this background, the objective of this registry is to assess the burden of valvular heart diseases and explore their clinical correlates in the most diverse area of the United States.
- Conditions
- Valvular Heart Disease
- Keywords
- valvular heart disease, race, ethnicity, diversity, mitral valve, aortic valve, tricuspid valve, pulmonary valve, stenosis, regurgitation, echocardiography
- Medical subject headings
- Heart Valve Diseases, Constriction, Pathologic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Race - American Indian or Alaska Native | Being identified as American Indian or Alaska Native | |
| Race - Asian | Being identified as Asian | |
| Race - Black or African-American | Being identified as Black or African-American | |
| Race - Native Hawaiian or Other Pacific Islander | Being identified as Native Hawaiian or Other Pacific Islander | |
| Race - White | Being identified as White | |
| Ethnicity - Spanish/Hispanic/Latino | Being identified as Spanish/Hispanic/Latino |
What is being measured
The primary outcome is the main question the study is designed to answer.
Racial/ethnical based differences in baseline characteristics and valvular heart disease
Baseline characteristics among pre-defined racial/ethnical groups will be compared for each valvular heart disease
Measured: Baseline
Prevalence of Valvular Heart Disease
Prevalence of each valvular heart disease will be compared among pre-defined racial/ethnical groups
Measured: Up to 10 years
All-cause mortality
All-cause mortality according to valvular heart disease and racial/ethnical group
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Jan 2010
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azeem Latib, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453526
- Sponsor's protocol ID
- 2022-13933
- Status last verified
- Jan 2025
- First submitted
- 1 Jul 2022
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Echarte-Morales J, Scotti A, Bonnet G, Torrado J, Sturla M, Coisne A, Ludwig S, Barzallo D, Escabia C, Chandra A, Kodesh A, Aftab A, Granada JF, Ho EC, Jorde UP, Rodriguez CJ, Slipczuk L, Garcia MJ, Latib A. Racial and ethnic disparities in patients with severe tricuspid regurgitation: The Bronx-Valve registry. Int J Cardiol. 2025 Feb 15;421:132889. doi: 10.1016/j.ijcard.2024.132889. Epub 2024 Dec 6.
PubMed 39647784Scotti A, Sturla M, Echarte-Morales J, Ho EC, Millin A, Coisne A, Ludwig S, Leone PP, Rosiene J, Granada JF, Goldberg Y, Pu M, Jorde UP, Slipczuk L, Rodriguez CJ, Garcia MJ, Latib A. Burden of Valvular Heart Diseases in a Racially and Ethnically Diverse Population: The Bronx-Valve Registry. J Am Heart Assoc. 2025 Jan 21;14(2):e035378. doi: 10.1161/JAHA.124.035378. Epub 2025 Jan 16.
PubMed 39817520
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Valvular Heart Diseases in an Ethnical/Racial Diverse Background of the United States: the Bronx-Valve Registry
- ClinicalTrials.gov ID
- NCT05453526
- Acronym / sponsor ID
- 2022-13933
- Conditions
- Valvular Heart Disease
- Keywords
- valvular heart disease, race, ethnicity, diversity, mitral valve, aortic valve, tricuspid valve, pulmonary valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330,570 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Jul 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 Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams. Valvular heart disease (VHD) is a major focus of cardiovascular medicine, but limited data are available for racial and ethnic minorities. The aim was to assess the burden and clinical correlates of VHD in a highly diverse area of the United States.
Detailed description
Cardiovascular disease is the leading cause of death in the general US population. Although the burden of valvular heart disease is increasing due to a rapidly aging population, patients can benefit from improved and more accessible imaging modalities, and novel minimally invasive treatments. However, medical knowledge and technological developments might not be generalizable to all patient backgrounds due to lack of diversity in scientific literature.
Historically, clinical trials testing new treatment modalities have lacked equitable inclusion of people coming from racial/ethnic minority groups. Similarly, epidemiological studies have focused on specific patient subsets with no direct comparisons with the other backgrounds. The Bronx county (New York, USA) is considered by the US Census as the most diverse area in the country, having the highest overwhelming concentration of non-white populations and being the only borough in all of New York City to be almost exclusively populated by non-white enclaves. These demographic characteristics make this county ideal to assess how the prevalence and the clinical correlates of valvular heart diseases might vary among diverse populations.
On this background, the objective of this registry is to assess the burden of valvular heart diseases and explore their clinical correlates in the most diverse area of the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Race - American Indian or Alaska Native | – | –Being identified as American Indian or Alaska Native |
| Race - Asian | – | –Being identified as Asian |
| Race - Black or African-American | – | –Being identified as Black or African-American |
| Race - Native Hawaiian or Other Pacific Islander | – | –Being identified as Native Hawaiian or Other Pacific Islander |
| Race - White | – | –Being identified as White |
| Ethnicity - Spanish/Hispanic/Latino | – | –Being identified as Spanish/Hispanic/Latino |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing echocardiographic assessment at Montefiore Medical Center (Bronx, NY, USA) will be included in this registry.
Key inclusion criteria (2 listed)
- Minimum age of 18 years old
- Undergoing transthoracic or transesophageal echocardiographic assessment at Montefiore Medical Center or affiliated institutions in the Bronx (NY, USA)
Key exclusion criteria (2 listed)
- Age below 18 years old
- No available information regarding race or ethnicity
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
Racial/ethnical based differences in baseline characteristics and valvular heart disease
Time frame: Baseline
Baseline characteristics among pre-defined racial/ethnical groups will be compared for each valvular heart disease
Prevalence of Valvular Heart Disease
Time frame: Up to 10 years
Prevalence of each valvular heart disease will be compared among pre-defined racial/ethnical groups
All-cause mortality
Time frame: Up to 10 years
All-cause mortality according to valvular heart disease and racial/ethnical group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Results publication: PubMed 39647784Echarte-Morales J, Scotti A, Bonnet G, Torrado J, Sturla M, Coisne A, Ludwig S, Barzallo D, Escabia C, Chandra A, Kodesh A, Aftab A, Granada JF, Ho EC, Jorde UP, Rodriguez CJ, Slipczuk L, Garcia MJ, Latib A. Racial and ethnic disparities in patients with severe tricuspid regurgitation: The Bronx-Valve registry. Int J Cardiol. 2025 Feb 15;421:132889. doi: 10.1016/j.ijcard.2024.132889. Epub 2024 Dec 6.
- Results publication: PubMed 39817520Scotti A, Sturla M, Echarte-Morales J, Ho EC, Millin A, Coisne A, Ludwig S, Leone PP, Rosiene J, Granada JF, Goldberg Y, Pu M, Jorde UP, Slipczuk L, Rodriguez CJ, Garcia MJ, Latib A. Burden of Valvular Heart Diseases in a Racially and Ethnically Diverse Population: The Bronx-Valve Registry. J Am Heart Assoc. 2025 Jan 21;14(2):e035378. doi: 10.1161/JAHA.124.035378. Epub 2025 Jan 16.
- Individual participant dataSharing planned: Undecided
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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.
Azeem Latib, MD principal investigator
Montefiore Medical Center
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 Montefiore Medical Center 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Racial/ethnical based differences in baseline characteristics and valvular heart disease (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05453526, 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 3 Feb 2025.