Representation of black patients in randomized clinical trials of heart failure with reduced ejection fraction

Aim: The “2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure” replaces the “2013 ACCF/AHA Guideline for the Management of Heart Failure” and the “2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure.” The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure. Methods: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021. Structure: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients’ interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.

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“…Many aspects of GDMT have been inadequately studied by population subgroups, largely as a result of clinical trial underrepresentation. 61–65…”

Section: Special Populationsmentioning

confidence: 99%

2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines

et al. 2022

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“…The underrepresentation of Black patients within clinical trials remains a major healthcare issue in the USA [ 17 ]. Structural racism and discrimination undoubtedly exist in the US healthcare and may play a major role in the disparities in health, access to health care and enrollment in clinical trials for Black patients in the USA.…”

Section: Discussionmentioning

confidence: 99%

Clinical Trial Participation and COVID-19: a Descriptive Analysis from the American Heart Association’s Get With The Guidelines Registry

Shah

Reyes-Miranda

Bradley

et al. 2022

J. Racial and Ethnic Health Disparities

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As COVID-19 cases begin to decrease in the USA, learning from the pandemic experience will provide insights regarding disparities of care delivery. We sought to determine if specific populations hospitalized with COVID-19 are equally likely to be enrolled in clinical trials. We examined patients hospitalized with COVID-19 at centers participating in the American Heart Association’s COVID-19 CVD Registry. The primary outcome was odds of enrollment in a clinical trial, according to sex, race, and ethnicity. Among 14,397 adults hospitalized with COVID-19, 9.5% ( n = 1,377) were enrolled in a clinical trial. The proportion of enrolled patients was the lowest for Black patients (8%); in multivariable analysis, female and Black patients were less likely to be enrolled in a clinical trial related to COVID-19 compared to men and other racial groups, respectively. Determination of specific reasons for the disparities in trial participation related to COVID-19 in these populations should be further investigated.

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“…[ 38 ] The proportion of Black and Hispanic patients in HF clinical trials appears to be falling despite the increasing ethnic diversity of the US. [ 38 ] Lack of diversity and cultural competency of trial investigators is a barrier to enrolment of diverse individuals. [ 39 ] These same populations are underrepresented as clinical trial investigators and leaders.…”

Section: Barriers To Optimal Gdmt Prescribing In Hf For Black Hispani...mentioning

confidence: 99%

Unequitable Heart Failure Therapy for Black, Hispanic and American-Indian Patients

2022

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Despite the high prevalence of heart failure among Black and Hispanic populations, patients of colour are frequently under-prescribed guideline-directed medical therapy (GDMT) and American-Indian populations are not well characterised. Clinical inertia, financial toxicity, underrepresentation in trials, non-trustworthy medical systems, bias and structural racism are contributing factors. There is an urgent need to develop evidence-based strategies to increase the uptake of GDMT for heart failure in patients of colour. Postulated strategies include prescribing all GDMT upon first encounter, aggressive outpatient uptitration of GDMT, intervening upon social determinants of health, addressing bias and racism through changing processes or policies that unfairly disadvantage patients of colour, engagement of stakeholders and implementation of national quality improvement programmes.

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Representation of black patients in randomized clinical trials of heart failure with reduced ejection fraction

Cited by 29 publications

References 61 publications

2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines

2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines

Clinical Trial Participation and COVID-19: a Descriptive Analysis from the American Heart Association’s Get With The Guidelines Registry

Unequitable Heart Failure Therapy for Black, Hispanic and American-Indian Patients

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