Table 2.
Inclusion and exclusion criteria for the DELIVER study.
Table adapted from ClinicalTrials.gov [33]
| Inclusion | Exclusion |
|---|---|
| Aged ≥ 40 years |
Receiving an SGLT2 inhibitor < 4 weeks prior to randomisation Type 1 diabetes mellitus |
| Symptomatic HF (NYHA class II–IV) ≥ 6 weeks before enrolment and at least intermittent need for diuretics |
eGFR < 25 mL/min/1.73 m2 Systolic BP < 95 mmHg or ≥ 160 mmHg if not on ≥ 3 BP-lowering medications, or ≥ 180 mmHg irrespective of treatments |
| LVEF > 40% and evidence of structural heart disease documented by the recent echocardiogram and/or cardiac MR within the last 12 months | MI, unstable angina, coronary revascularization, AF ablation, valve repair/replacement < 12 weeks before enrolment |
| Elevated NT-pro BNP levels | Planned coronary revascularization, AF ablation or valve repair/replacement |
| Ambulatory and hospitalised patients can be enrolled. Patients hospitalised for HF must not receive intravenous HF medications for at least 24 h prior to enrolment |
Stroke or TIA < 12 weeks before enrolment Alternative diagnoses which could account for the patient’s HF symptoms and signs BMI > 50 kg/m2 |
BMI body mass index, BP blood pressure, eGFR estimated glomerular filtration rate, HF heart failure, LVEF left ventricular ejection fraction, MI myocardial infarction, NT-pro BNP N-terminal pro B-type natriuretic peptide, NYHA New York Heart Association, SGLT2 sodium–glucose co-transporter 2, TIA transient ischaemic attack