Race and ethnicity in the landmark hypertrophic cardiomyopathy trials: representation against population, site-catchment, and disease-referenced expectations
- 1University of Washington
Abstract
BACKGROUNDHypertrophic cardiomyopathy (HCM) is a pan-ethnic disease, at least as common in Black as in White Americans, yet Black patients reach specialist care later, undergo septal reduction less often, and die sooner. Whether the defining trials enrolled representatively is unknown. We sought to measure Black participation in the landmark HCM trials against three expectations of increasing stringency, and to test whether trial site geography or quantitative eligibility thresholds account for the shortfall.
METHODSOf 197 registered interventional HCM trials, 32 met prespecified landmark tiers; demographics were extracted for 16 and 13 reported race. The Black share of Black plus White participants was pooled by random-effects meta-analysis and compared with the US adult population, with each trials own site counties, and with a disease-referenced echocardiographic expectation. Site geography and eligibility thresholds were tested using site addresses, census data, and NHANES.
RESULTSAcross 13 trials, 70 of 1,780 Black or White participants were Black. The pooled Black share was 3.98% (95% CI 2.68-5.86), against a population expectation of 16.3%, giving a participation-to-prevalence ratio (PPR) of 0.24 (95% CI 0.16-0.36), the lowest of any racial and/or ethnic minority group. The clinical trial site network reached 63.7% of Black and 47.5% of White US adults, with geospatial analysis predicting 26.4% Black enrollment; however, every trial fell below this expectation. Quantitative eligibility thresholds closed only 2.0% of the enrollment gap.
CONCLUSIONSBlack participation was about one quarter of the population expectation. Neither site geography nor eligibility thresholds explain it.
CLINICAL PERSPECTIVEO_ST_ABSWhat is New?C_ST_ABSO_LIAcross the 13 landmark hypertrophic cardiomyopathy trials that posted race, 70 of 1,780 participants recorded as Black or White were Black, a pooled share of 3.98% against a population expectation of 16.3%. C_LIO_LIThe US counties hosting the trials own sites predicted 26.4% Black enrollment, and every trial enrolled below its own catchment expectation. C_LIO_LINeither site geography nor quantitative eligibility thresholds explain the shortfall, because the site network reached 63.7% of Black adults and the extracted thresholds closed 2.0% of the gap in Black enrollment. C_LI
What are the Clinical Implications?O_LIBlack patients with hypertrophic cardiomyopathy live within reach of the sites that enrolled them least, so clinicians should treat trial referral as a distinct clinical act and audit their own referral patterns. C_LIO_LIFuture trials should report screening, referral, and offer by race prospectively, and should benchmark enrollment against the catchment population of their own sites. C_LIO_LIThe loss occurs downstream of geography and eligibility, in site recruitment conduct and in the referral pathway, and that is where measurement and correction must begin. C_LI
Related
- A late bloom at the apex: development of apical hypertrophic cardiomyopathy phenotype in advanced age
- Research trends and hotspot analysis of sudden cardiac death in hypertrophic cardiomyopathy : A bibliometric analysis
- Managing a mavacamten non-responder in obstructive hypertrophic cardiomyopathy: A case report
- Percutaneous endomyocardial ablation as a septal reduction strategy in symptomatic obstructive hypertrophic cardiomyopathy: A 20-year single-center observational experience.
- Transatrial air-assisted epicardial ventricular tachycardia ablation for hypertrophic cardiomyopathy and management of postprocedural right atrial thrombus.
BibTeX
@misc{kim2026race,
title = {{Race and ethnicity in the landmark hypertrophic cardiomyopathy trials: representation against population, site-catchment, and disease-referenced expectations}},
author = {D. S. Kim and A. P. Wescott and B. J. Petek and J. W. O'Sullivan and F. Moussavi-Harami and D. Owens and A. Lawrie and C. M. Kramer and F. Rader and V. N. Parikh and M. T. Wheeler and E. Yang and E. A. Ashley and A. Masri},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.24.26363977},
url = {https://www.medrxiv.org/content/10.64898/2026.09.24.26363977v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - Race and ethnicity in the landmark hypertrophic cardiomyopathy trials: representation against population, site-catchment, and disease-referenced expectations
AU - D. S. Kim
AU - A. P. Wescott
AU - B. J. Petek
AU - J. W. O'Sullivan
AU - F. Moussavi-Harami
AU - D. Owens
AU - A. Lawrie
AU - C. M. Kramer
AU - F. Rader
AU - V. N. Parikh
AU - M. T. Wheeler
AU - E. Yang
AU - E. A. Ashley
AU - A. Masri
PY - 2026
DA - 2026/09/24
PB - medRxiv
DO - 10.64898/2026.09.24.26363977
UR - https://www.medrxiv.org/content/10.64898/2026.09.24.26363977v1
AB - BACKGROUNDHypertrophic cardiomyopathy (HCM) is a pan-ethnic disease, at least as common in Black as in White Americans, yet Black patients reach specialist care later, undergo septal reduction less often, and die sooner. Whether the defining trials enrolled representatively is unknown. We sought to measure Black participation in the landmark HCM trials against three expectations of increasing stringency, and to test whether trial site geography or quantitative eligibility thresholds account for the shortfall. METHODSOf 197 registered interventional HCM trials, 32 met prespecified landmark tiers; demographics were extracted for 16 and 13 reported race. The Black share of Black plus White participants was pooled by random-effects meta-analysis and compared with the US adult population, with each trials own site counties, and with a disease-referenced echocardiographic expectation. Site geography and eligibility thresholds were tested using site addresses, census data, and NHANES. RESULTSAcross 13 trials, 70 of 1,780 Black or White participants were Black. The pooled Black share was 3.98% (95% CI 2.68-5.86), against a population expectation of 16.3%, giving a participation-to-prevalence ratio (PPR) of 0.24 (95% CI 0.16-0.36), the lowest of any racial and/or ethnic minority group. The clinical trial site network reached 63.7% of Black and 47.5% of White US adults, with geospatial analysis predicting 26.4% Black enrollment; however, every trial fell below this expectation. Quantitative eligibility thresholds closed only 2.0% of the enrollment gap. CONCLUSIONSBlack participation was about one quarter of the population expectation. Neither site geography nor eligibility thresholds explain it. CLINICAL PERSPECTIVEO_ST_ABSWhat is New?C_ST_ABSO_LIAcross the 13 landmark hypertrophic cardiomyopathy trials that posted race, 70 of 1,780 participants recorded as Black or White were Black, a pooled share of 3.98% against a population expectation of 16.3%. C_LIO_LIThe US counties hosting the trials own sites predicted 26.4% Black enrollment, and every trial enrolled below its own catchment expectation. C_LIO_LINeither site geography nor quantitative eligibility thresholds explain the shortfall, because the site network reached 63.7% of Black adults and the extracted thresholds closed 2.0% of the gap in Black enrollment. C_LI What are the Clinical Implications?O_LIBlack patients with hypertrophic cardiomyopathy live within reach of the sites that enrolled them least, so clinicians should treat trial referral as a distinct clinical act and audit their own referral patterns. C_LIO_LIFuture trials should report screening, referral, and offer by race prospectively, and should benchmark enrollment against the catchment population of their own sites. C_LIO_LIThe loss occurs downstream of geography and eligibility, in site recruitment conduct and in the referral pathway, and that is where measurement and correction must begin. C_LI
ER -