Table 3.

Similarities and differences between the DELIVER and EMPEROR-preserved trials.

Table adapted from ClinicalTrials.gov [33] and Anker et al. [32]

	DELIVER trial (dapagliflozin)	EMPEROR-preserved (empagliflozin)
Study participants	~ 6100	~ 5988
Anticipated follow-up and dates of the study	Up to ~ 33 months	Median ~ 24 months
	August 2018–June 2021	March 2017–November 2020
Inclusion criteria	Aged ≥ 40 years	Aged ≥ 18 years
	Symptomatic HF (NYHA class II–IV) ≥ 6 weeks before enrolment and at least intermittent need for diuretics	Symptomatic HF (NYHA class II–IV) ≥ 3 months before enrolment on a stable dose of diuretics for 1 week, if prescribed
	Ambulatory and hospitalised patients can be enrolled, people with HHF cannot receive IV diuretics for ≥ 24 h prior to enrolment	Patients admitted with ADHF cannot be enrolled if ≤ 1 week of screening or screening period
Definition of HFpEF	LVEF > 40% and structural heart disease documented by echocardiogram and/or cardiac MR ≤ 12 months	LVEF > 40% with structural heart disease ≤ 6 months, or HHF ≤ 12 months prior to visit 1
	Elevated NT-pro BNP levels	Elevated NT-proBNP  (a) > 300 pg/ml for patients without AF  (b) > 900 pg/ml for patients with AF
Key differences in exclusion criteria	eGFR < 25 mL/min/1.73 m2	eGFR < 20 ml/min/1.73 m2 or requiring dialysis
	SBP < 95 mmHg or ≥ 160 mmHg if ≤ 3 BP drugs, or ≥ 180 mmHg irrespective of treatment	SBP ≥ 180 mmHg, symptomatic hypotension and/or SBP ≤ 100 mmHg
	People with ADHF can be enrolled if not received IV diuretics ≥ 24 h	ADHF requiring IV diuretics, vasodilator or mechanical support ≤ 1 week of screening or during the screening period
	MI, unstable angina, coronary revascularization, AF ablation, valve repair/replacement < 12 weeks	MI, CABG or major cardiovascular surgery, stroke or TIA in past 90 days prior to visit 1
	Planned coronary revascularization, AF ablation or valve repair/replacement
	Stroke or TIA < 12 weeks before enrolment	Heart transplant recipient, or listed for heart transplant
	BMI > 50 kg/m2	Indication of liver disease
Primary outcomes	Time to first occurrence of either cardiovascular death, HHF or urgent heart failure visit	Time to first occurrence of the combined risk for cardiovascular death or HHF
Secondary outcomes	Number of HHF and cardiovascular death	HHF events and cardiovascular death
	Death from any cause	Death from any cause
	Proportion of patients with worsened NYHA class	All-cause hospitalisation
	Changes in clinical summary score of the KCCQ	Changes in eGFR, time to chronic dialysis, renal transplant or sustained reduction of eGFR, time to onset of diabetes Changes in clinical summary score of the KCCQ

ADHF acute decompensated heart failure, AF atrial fibrillation, CABG coronary artery bypass graft, eGFR estimated glomerular filtration rate, HHF hospitalisation for heart failure, IV intravenous, KCCQ Kansas City Cardiomyopathy Questionnaire, lvef left ventricular ejection fraction, MI myocardial infarction, MRI magnetic resonance imaging, NT-pro BNP N-terminal pro B-type natriuretic peptide, NYHA New York Heart Association, SBP systolic blood pressure, TIA transient ischaemic attack