Clinical trial NCT05453526: The Bronx-Valve Registry
Official title: Burden of Valvular Heart Diseases in an Ethnical/Racial Diverse Background of the United States: the Bronx-Valve Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valvular Heart Disease
Keywords: valvular heart disease
race
ethnicity
diversity
mitral valve
aortic valve
tricuspid valve
pulmonary valve
stenosis
regurgitation
echocardiography
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 330570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients undergoing echocardiographic assessment at Montefiore Medical Center (Bronx, NY, USA) will be included in this registry.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years old
* Undergoing transthoracic or transesophageal echocardiographic assessment at Montefiore Medical Center or affiliated institutions in the Bronx (NY, USA)

Exclusion Criteria:

* Age below 18 years old
* No available information regarding race or ethnicity

Primary outcomes:
measure: Racial/ethnical based differences in baseline characteristics and valvular heart disease
timeFrame: Baseline
measure: Prevalence of Valvular Heart Disease
timeFrame: Up to 10 years
measure: All-cause mortality
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Azeem Latib, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Scotti 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.