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. 2025 Jun 17;14(12):e037810.
doi: 10.1161/JAHA.124.037810. Epub 2025 Jun 11.

Race and Ethnicity in Heart Failure Trials: Time to Update Recommended Categories for Global Relevance

Mingming Yang  1   2 , Toru Kondo  2   3 , Pooja Dewan  2 , Akshay S Desai  4 , Antonio S Sibulo Jr  5 , Carolyn S P Lam  6 , Chern-En Chiang  7 , Efrain A Gomez  8 , Felipe A Martinez  9 , Jorge Thierer  10 , Jose C Nicolau  11 , Jose F Kerr Saraiva  12 , Masafumi Kitakaze  13 , Milton Packer  14 , Muthiah Vaduganathan  4 , Pham Nguyen Vinh  15 , William T Abraham  16 , Pardeep S Jhund  2 , Scott D Solomon  4 , John J V McMurray  2
Affiliations

Race and Ethnicity in Heart Failure Trials: Time to Update Recommended Categories for Global Relevance

Mingming Yang et al. J Am Heart Assoc. .

Abstract

Background: The collection of race and ethnicity data in clinical trials using standardized categories is recommended by the US Food and Drug Administration, although this is primarily for domestic reasons. The applicability and understanding of the categories in multinational trials are uncertain.

Methods: We analyzed patient-level data from 13 major heart failure trials, examining race and ethnicity data recorded by country, as recommended by the Food and Drug Administration: "American Indian or Alaska Native," "Asian," "Black or African American," "Native Hawaiian or Other Pacific Islander," and "White" for race and "Hispanic or Latino" as a minimum for ethnicity (with an expanded list of ethnicities available).

Results: Of the 54 087 patients studied, approximately 32.3% were women. In the United States, 77% of patients were reported to be of White race and 19% of Black race with very few assigned to another race category (1% Asian, 0.7% Native American, 0.2% Native Hawaiian or other Pacific islander, and 1.4% "other"). In Europe, race was almost uniformly reported as White, and a similar racial homogeneity was reported in Asia (Asian race). Conversely, in Latin America, 8.9% of patients were described as "American Indian or Alaska Native," with a very high proportion in specific countries (eg, 36% in Guatemala and 21% in Mexico). In the United States, 6.2% of participants were reported to have Hispanic/Latino ethnicity but most patients in Latin America were reported to have this ethnicity; conversely, few patients had this ethnicity reported outside the Americas, including in Spain and Portugal. Among patients designated as Asian race, specific ethnicities (eg, Indian, Japanese etc) almost completely overlapped with the country of origin.

Conclusions: This study highlights the challenges of applying standardized race and, particularly, ethnicity categories in global clinical trials. A multistakeholder approach is needed to improve the collection of race and ethnicity data in clinical trials.

Keywords: FDA; ethnicity; heart failure; multinational trials; race.

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Conflict of interest statement

Dr Yang has received Global CardioVascular Clinical Trialists Young Trialist Grant and travel grants from AstraZeneca and Bayer. Dr Kondo reports speaker fees from Abbott, Ono Pharma, Otsuka Pharma, Novartis, AstraZeneca, Bristol‐Myers Squibb, and Abiomed. Dr Desai reports consulting fees from Abbott, Biofourmis, Boston Scientific, Boehringer Ingelheim, DalCor Pharmaceuticals, and Regeneron, grant support (paid to Brigham and Women's Hospital) and consulting fees from Alnylam Pharmaceuticals and Novartis, and advisory board fees from Corvidia and Relypsa. Dr Sibulo Jr has received research grants from Novartis. Dr Lam is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from AstraZeneca, Bayer, Boston Scientific, and Roche Diagnostics; has served as a consultant or on the advisory board/steering committee/executive committee for Actelion, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Cytokinetics, Darma Inc, Us2.ai, Janssen Research & Development LLC, Medscape, Merck, Novartis, Novo Nordisk, Radcliffe Group Ltd, Roche Diagnostics, Sanofi, and WebMD Global LLC; and serves as the cofounder and nonexecutive director of Us2.ai. Dr Chiang received personal fee from Astrazeneca, Boehringer Ingelheim, Daiichi‐Sankyo, Eli Lilly, Menarini, MSD, Novartis, Pfizer, and Sanofi. Dr Martinez has received personal fees from AstraZeneca, Novartis, Gador, Baliarda, Pfizer, Bayer, Bago.

Dr Thierer has received support for lectures and advisory boards from AstraZeneca, Boehringer Ingelheim, and Pfizer. Dr. Nicolau has received research grants from Amgen, Astrazeneca, Bayer, CSL Behring, Daiichi Sankyo, Dalcor, Esperion, Janssen, Novartis, Novonordisk, Sanofi, Vifor, personal fees from Libbs, and is a recipient of a Scholarship from the National Council of Scientific and Technological Development (Conselho Nacional de Desenvolvimento Científico e Tecnológico – CNPq) #3012242/2017–8. Dr Saraiva has received grants or fees for working on clinical trials, consultancy, advisory board or steering committee membership, and other activities from AstraZeneca, Novo Nordisk, Bayer, Boehringer Ingelheim, Novartis, Merck Sharp & Dohme, and Janssen. Dr Kitakaze has received grants or contracts from the Japanese government through the Japan Agency for Medical Research and Development, Japan Heart Foundation, and has received payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from AstraZeneca, Ono, Novartis, Tanabe‐Mitsubishi, Japan Medical Data Center, Takeda, Pfizer, Daiichi Sankyo, Otsuka, Sanofi, Boehringer Ingelheim, Amgen, Kowa, Toyama‐Kagaku, Kureha, Viatris, and Mochida. Dr Packer reports consulting fees from AbbVie, Akcea, Actavis, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cardiorentis, Daiichi Sankyo, Gilead, Johnson & Johnson, Novo Nordisk, Pfizer, Relypsa, Sanofi, Synthetic Biologics, and Theravance. Dr Vaduganathan has received research grant support, advisory boards or speaker engagements with American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Chiesi, Cytokinetics, Lexicon Pharmaceuticals, Merck, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; and participated on clinical trial committees for studies sponsored by AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. Dr Vinh received either personal or institutional research support for DELIVER from AstraZeneca. Dr Abraham reports personal fees from Abbott, consulting fees from Boehringer Ingelheim, Impulse Dynamics, and Respicardia; has received salary support from V‐Wave Medical; and has received research support from the National Heart, Lung, and Blood Institute, all for studies performed within the heart failure arena. Dr. Jhund has received speaker fees from AstraZeneca, Novartis, Alkem Metabolics, ProAdWise Communications, Sun Pharmaceuticals, and Intas Pharmaceuticals; has received advisory board fees from AstraZeneca, Boehringer Ingelheim, and Novartis; has received research funding from AstraZeneca, Boehringer Ingelheim, Analog Devices Inc; his employer the University of Glasgow has been remunerated for clinical trial work from AstraZeneca, Bayer AG, Novartis, and Novo Nordisk; and is the director of Global Clinical Trial Partners. Dr Solomon has received research grants from Actelion, Alnylam, Amgen, AstraZeneca, Bellerophon, Bayer, Bristol Myers Squibb, Celladon, Cytokinetics, Eidos, Gilead, GlaxoSmithKline, Ionis, Lilly, Mesoblast, MyoKardia, National Institutes of Health/National Heart, Lung, and Blood Institute, Neurotronik, Novartis, Novo Nordisk, Respicardia, Sanofi Pasteur, Theracos, and S2.AI; and has consulted for Abbott, Action, Akros, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardior, Cardurion, Corvia, Cytokinetics, Daiichi‐Sankyo, GlaxoSmithKline, Lilly, Merck, Myokardia, Novartis, Roche, Theracos, Quantum Genomics, Cardurion, Janssen, Cardiac Dimensions, Tenaya, Sanofi‐Pasteur, Dinaqor, Tremeau, CellPro‐Thera, Moderna, American Regent, and Sarepta. Dr McMurray has received payments through Glasgow University from work on clinical trials, consulting and other activities from Amgen, AstraZeneca, Bayer, Cardurion, Cytokinetics, GlaxoSmithKline, KBP Biosciences, and Novartis; has received personal consultancy fees from Alnylam Pharma, Bayer, Bristol Myers Squibb, George Clinical PTY Ltd, Ionis Pharma, Novartis, Regeneron Pharma, and River 2 Renal Corporation; has received personal lecture fees from Abbott, Alkem Metabolics, AstraZeneca, Blue Ocean Scientific Solutions Ltd, Boehringer Ingelheim, Canadian Medical and Surgical Knowledge, Emcure Pharma Ltd, Eris Lifesciences, European Academy of CME, Hikma Pharmaceuticals, Imagica health, Intas Pharma, J.B. Chemicals & Pharma. Ltd, Lupin Pharma, Medscape/Heart, ProAdWise Communications, Radcliffe Cardiology, Sun Pharma, The Corpus, Translation Research Group, and Translational Medicine Academy; and is a director of Global Clinical Trial Partners Ltd. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1
Figure 1. Race of patients with HF according to country/region.
A, Europe; B, Americas; C, Asia; D, Other countries (Middle East/Sub‐Saharan Africa/Australia/Russia). Trials included CIBIS‐II, MERIT‐HF, EMPHASIS‐HF, ATMOSPHERE, PARADIGM‐HF, DAPA‐HF, CHARM (Preserved, Added, Alternative), I‐Preserve, TOPCAT‐Americas, PARAGON‐HF, and DELIVER. Only countries with ≥50 patients are included. ATMOSPHERE indicates Aliskiren Trial to Minimize Outcomes in Patients With Heart Failure; CHARM, Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity; CIBIS‐II, Cardiac Insufficiency Bisoprolol Study II; DAPA‐HF, Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure; DELIVER, Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure; EMPHASIS‐HF, Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure; HF, heart failure; I‐Preserve, Irbesartan in Heart Failure With Preserved Ejection Fraction; MERIT‐HF, Metoprolol CR/XL (Metoprolol Succinate Extended‐Release) Randomized Intervention Trial in Congestive Heart Failure; PARADIGM‐HF, Prospective Comparison of ARNI (Angiotensin Receptor‐Neprilysin Inhibitors) With ACEI (Angiotensin‐Converting Enzyme Inhibitor) to Determine Impact on Global Mortality and Morbidity in Heart Failure; PARAGON‐HF, Prospective Comparison of ARNI (Angiotensin Receptor‐Neprilysin Inhibitors) with ARB (Angiotensin Receptor Blocker) Global Outcomes in HF (Heart Failure) With Preserved Ejection Fraction; and TOPCAT‐Americas, Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist.
Figure 2
Figure 2. Race and ethnicity according to country/region.
A, Race in countries/regions where >10% of participants were “other.” Only trials with supplemental “other” race data are included in this figure: ATMOSPHERE, PARADIGM‐HF, DAPA‐HF, PARAGON‐HF, and DELIVER; B, Ethnicity in countries/regions where >10% of participants were not of Hispanic/Latino ethnicity. Only trials with supplemental “Not Hispanic/Latino” ethnicity data are included in this figure: ATMOSPHERE, PARADIGM‐HF, and PARAGON‐HF. Only countries with ≥50 patients are included. ATMOSPHERE indicates Aliskiren Trial to Minimize Outcomes in Patients With Heart Failure; DAPA‐HF, Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure; DELIVER, Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure; PARADIGM‐HF, Prospective Comparison of ARNI (Angiotensin Receptor‐Neprilysin Inhibitors) With ACEI (Angiotensin‐Converting Enzyme Inhibitor) to Determine Impact on Global Mortality and Morbidity in Heart Failure; and PARAGON‐HF, Prospective Comparison of ARNI (Angiotensin Receptor‐Neprilysin Inhibitors) with ARB (Angiotensin Receptor Blocker) Global Outcomes in HF (Heart Failure) With Preserved Ejection Fraction.
Figure 3
Figure 3. Ethnicity of patients with HF according to country/region.
A, Europe; B, Americas; C, Asia; D, Other countries (Middle East/Sub‐Saharan Africa/Australia/Russia). Trials included ATMOSPHERE, PARADIGM‐HF, DAPA‐HF, I‐Preserve, TOPCAT‐Americas, PARAGON‐HF, DELIVER. Only countries with ≥50 patients are included. ATMOSPHERE indicates Aliskiren Trial to Minimize Outcomes in Patients With Heart Failure; DAPA‐HF, Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure; DELIVER, Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure; HF, heart failure; I‐Preserve, Irbesartan in Heart Failure With Preserved Ejection Fraction; PARADIGM‐HF, Prospective Comparison of ARNI (Angiotensin Receptor‐Neprilysin Inhibitors) With ACEI (Angiotensin‐Converting Enzyme Inhibitor) to Determine Impact on Global Mortality and Morbidity in Heart Failure; PARAGON‐HF, Prospective Comparison of ARNI (Angiotensin Receptor‐Neprilysin Inhibitors) with ARB (Angiotensin Receptor Blocker) Global Outcomes in HF (Heart Failure) With Preserved Ejection Fraction; and TOPCAT‐Americas, Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist.
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