Results
HFpEF
MAY, RECRUITMENT
Patient recruitment took place at a single center (OCMR, Oxford, UK) from March 2018 to May 2020. A total of 101 patients performed a screening visit, and 72 patients were eventually enrolled and randomly assigned treatment. Of those, 36 patients were in the HFrEF cohort (19 placebo and 17 empagliflozin) and 36 in the HFpEF cohort (18 placebo and 18 empagliflozin). One patient who was randomized into the placebo arm of the study was excluded from data analysis of the PPS due to premature end of follow-up. The HFrEF cohort of patients was recruited and followed up in full before recruitment in the HFpEF cohort finished. Thus, because of the unprecedented global COVID-19 pandemic and far-reaching effects of national lockdowns, all face-to-face research activities were suspended from March 24, 2020, onward. This inability to conduct end-of-treatment visits after 12 weeks of treatment led to an exclusion of 13 (36.1%) patients from the randomized set and a subsequent numeric reduction of the PPS to 24 patients (13 on empagliflozin and 11 on placebo) in the HFpEF cohort.