Evaluation of the causes of sex disparity in heart failure trials

Holly Morgan; Aish Sinha; Margaret McEntegart; Suzanna Marie Hardman; Divaka Perera

doi:10.1136/heartjnl-2021-320696

Evaluation of the causes of sex disparity in heart failure trials

Holly Morgan, Aish Sinha, Margaret McEntegart, Suzanna Marie Hardman, Divaka Perera^*

^*Corresponding author for this work

Cardiovascular Research

Research output: Contribution to journal › Article › peer-review

11 Citations (Scopus)

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Abstract

Objectives: Cardiovascular disease is one of the leading causes of mortality and morbidity in women. Despite this, even in contemporary research, female patients are poorly represented in trials. This study aimed to explore reasons behind the sex disparity in heart failure (HF) trials. Methods: HF trials published in seven high-impact clinical journals (impact factor >20), between 2000 and 2020, were identified. Trials with over 300 participants of both sexes were included. Large HF registries, as well as population statistics, were also identified using the same criteria. Results: We identified 146 HF trials, which included 248 620 patients in total. The median proportion of female patients was 25.8%, with the lowest proportions seen in trials enrolling patients with ischaemic cardiomyopathy (17.9%), severe systolic dysfunction (left ventricular ejection fraction (LVEF) <35%) (21.4%) and those involving an invasive procedure (21.1%). The highest proportion of women was seen in trials assessing HF with preserved LVEF (51.6%), as well as trials including older participants (40.5%). Significant differences were seen between prevalence of female trial participants and population prevalence in all LVEF categories (25.8% vs 49.0%, p<0.01). Conclusions: A significant sex disparity was identified in HF trials, most visible in trials assessing patients with severely reduced LVEF and ischaemic aetiology. This is likely due to a complex interplay between enrolment bias and biological variation. Furthermore, the degree of both these aspects may vary according to trial type. Going forward, we should encourage all HF trials to appraise their recruitment log and suggest reasons for any reported sex disparity.

Original language	English
Article number	320696
Pages (from-to)	1547-1552
Number of pages	6
Journal	Heart
Volume	108
Issue number	19
Early online date	17 May 2022
DOIs	https://doi.org/10.1136/heartjnl-2021-320696
Publication status	Published - 1 Oct 2022

Keywords

Coronary Artery Disease
GENDER
Heart failure
Research Design

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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title = "Evaluation of the causes of sex disparity in heart failure trials",

abstract = "Objectives: Cardiovascular disease is one of the leading causes of mortality and morbidity in women. Despite this, even in contemporary research, female patients are poorly represented in trials. This study aimed to explore reasons behind the sex disparity in heart failure (HF) trials. Methods: HF trials published in seven high-impact clinical journals (impact factor >20), between 2000 and 2020, were identified. Trials with over 300 participants of both sexes were included. Large HF registries, as well as population statistics, were also identified using the same criteria. Results: We identified 146 HF trials, which included 248 620 patients in total. The median proportion of female patients was 25.8%, with the lowest proportions seen in trials enrolling patients with ischaemic cardiomyopathy (17.9%), severe systolic dysfunction (left ventricular ejection fraction (LVEF) <35%) (21.4%) and those involving an invasive procedure (21.1%). The highest proportion of women was seen in trials assessing HF with preserved LVEF (51.6%), as well as trials including older participants (40.5%). Significant differences were seen between prevalence of female trial participants and population prevalence in all LVEF categories (25.8% vs 49.0%, p<0.01). Conclusions: A significant sex disparity was identified in HF trials, most visible in trials assessing patients with severely reduced LVEF and ischaemic aetiology. This is likely due to a complex interplay between enrolment bias and biological variation. Furthermore, the degree of both these aspects may vary according to trial type. Going forward, we should encourage all HF trials to appraise their recruitment log and suggest reasons for any reported sex disparity. ",

keywords = "Coronary Artery Disease, GENDER, Heart failure, Research Design",

author = "Holly Morgan and Aish Sinha and Margaret McEntegart and Hardman, {Suzanna Marie} and Divaka Perera",

note = "Funding Information: Funding This work was supported by the British Heart Foundation (Fellowship FS/ CRTF/21/24190 to HM), the Medical Research Council (Fellowship MR/T029390/1 to AS) and the National Institute for Health Research (Biomedical Research Centre Award to Guy{\textquoteright}s and St Thomas{\textquoteright} NHSFT and King{\textquoteright}s College London). Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2022.",

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doi = "10.1136/heartjnl-2021-320696",

language = "English",

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AU - Sinha, Aish

AU - McEntegart, Margaret

AU - Hardman, Suzanna Marie

AU - Perera, Divaka

N1 - Funding Information: Funding This work was supported by the British Heart Foundation (Fellowship FS/ CRTF/21/24190 to HM), the Medical Research Council (Fellowship MR/T029390/1 to AS) and the National Institute for Health Research (Biomedical Research Centre Award to Guy’s and St Thomas’ NHSFT and King’s College London). Publisher Copyright: © Author(s) (or their employer(s)) 2022.

PY - 2022/10/1

Y1 - 2022/10/1

N2 - Objectives: Cardiovascular disease is one of the leading causes of mortality and morbidity in women. Despite this, even in contemporary research, female patients are poorly represented in trials. This study aimed to explore reasons behind the sex disparity in heart failure (HF) trials. Methods: HF trials published in seven high-impact clinical journals (impact factor >20), between 2000 and 2020, were identified. Trials with over 300 participants of both sexes were included. Large HF registries, as well as population statistics, were also identified using the same criteria. Results: We identified 146 HF trials, which included 248 620 patients in total. The median proportion of female patients was 25.8%, with the lowest proportions seen in trials enrolling patients with ischaemic cardiomyopathy (17.9%), severe systolic dysfunction (left ventricular ejection fraction (LVEF) <35%) (21.4%) and those involving an invasive procedure (21.1%). The highest proportion of women was seen in trials assessing HF with preserved LVEF (51.6%), as well as trials including older participants (40.5%). Significant differences were seen between prevalence of female trial participants and population prevalence in all LVEF categories (25.8% vs 49.0%, p<0.01). Conclusions: A significant sex disparity was identified in HF trials, most visible in trials assessing patients with severely reduced LVEF and ischaemic aetiology. This is likely due to a complex interplay between enrolment bias and biological variation. Furthermore, the degree of both these aspects may vary according to trial type. Going forward, we should encourage all HF trials to appraise their recruitment log and suggest reasons for any reported sex disparity.

AB - Objectives: Cardiovascular disease is one of the leading causes of mortality and morbidity in women. Despite this, even in contemporary research, female patients are poorly represented in trials. This study aimed to explore reasons behind the sex disparity in heart failure (HF) trials. Methods: HF trials published in seven high-impact clinical journals (impact factor >20), between 2000 and 2020, were identified. Trials with over 300 participants of both sexes were included. Large HF registries, as well as population statistics, were also identified using the same criteria. Results: We identified 146 HF trials, which included 248 620 patients in total. The median proportion of female patients was 25.8%, with the lowest proportions seen in trials enrolling patients with ischaemic cardiomyopathy (17.9%), severe systolic dysfunction (left ventricular ejection fraction (LVEF) <35%) (21.4%) and those involving an invasive procedure (21.1%). The highest proportion of women was seen in trials assessing HF with preserved LVEF (51.6%), as well as trials including older participants (40.5%). Significant differences were seen between prevalence of female trial participants and population prevalence in all LVEF categories (25.8% vs 49.0%, p<0.01). Conclusions: A significant sex disparity was identified in HF trials, most visible in trials assessing patients with severely reduced LVEF and ischaemic aetiology. This is likely due to a complex interplay between enrolment bias and biological variation. Furthermore, the degree of both these aspects may vary according to trial type. Going forward, we should encourage all HF trials to appraise their recruitment log and suggest reasons for any reported sex disparity.

KW - Coronary Artery Disease

KW - GENDER

KW - Heart failure

KW - Research Design

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SN - 1355-6037

VL - 108

SP - 1547

EP - 1552

JO - Heart

JF - Heart

IS - 19

M1 - 320696

ER -

Evaluation of the causes of sex disparity in heart failure trials

Abstract

Keywords

UN SDGs

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