BACKGROUND
The black population is generally underrepresented in randomized controlled trials
(RCTs). The representation of black individuals in heart failure with preserved EF
(HFpEF) RCTs has not been evaluated. We aim to characterize the representation of
black patients in major RCTs of chronic HFpEF therapies.
METHODS AND RESULTS
We conducted a comprehensive database search of PubMed and EMBASE, using the search
terms ‘African American’, ‘black’, ‘heart failure with preserved ejection fraction’,
‘heart failure’, ‘diastolic heart failure’, ‘treatment’, ‘therapy’, intervention’,
‘race’, ‘ethnicity’ and ‘randomized clinical trials’. Abstracts and conferences proceedings
were excluded, and no language restriction was applied. Our search yielded 17 RCTs:
15 for pharmacotherapies, one evaluating lifestyle modification, and one evaluating
diuretic therapy guided by a wireless pulmonary artery monitoring device. The trials
enrolled a total of 19,458 patients. Only nine trials of the 17 trials (52.9%) explicitly
reported enrollment of Blacks. There were 695 Blacks, accounting for 4.1% of the participants
in these nine trials. The TOPCAT trial recruited the largest number of Blacks (302),
accounting for 8.7% of the total enrolled participants. Only three out of the 17 RCTs
(17.6%) reported outcomes for Blacks. There was no difference in outcomes among Blacks
and non-blacks in these three RCTs.
CONCLUSION
Black patients are poorly represented in major HFpEF RCTs. Our systematic review reinforces
the need for adequate enrollment of Blacks in future RCTs of HFpEF to ensure that
the benefits and safety of future HFpEF therapies can be confirmed in this high-risk
population.
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© 2021 Published by Elsevier Inc.
