Table 2.
EMPULSE | DELIVER | SOLOIST-WHF | CHIEF-HF | EMPEROR | |
---|---|---|---|---|---|
Study drug | Empagliflozin 10 mg | Dapagliflozin 10 mg | Sotagliflozin | Canagliflozin | Empagliflozin 10 mg |
Population | Acute but stabilized heart failure with or without T2DM | HFpEF in patients with or without T2DM | Worsening HF in patients with T2D | Patients with heart failure, with or without T2D | HF with preserved or reduced EF, with or without T2D |
Sample size | 500 | 4700 | 6667 | 1900 |
5500 (preserved) 3350 (reduced) |
Key inclusion criteria |
Elevated NT-proBNP Hospital admission for worsening HF and haemodynamically stable Patients with HFrEF administered loop diuretics (unless contraindicated) |
Symptomatic HFpEF Elevated NT-proBNP eGFR ≥ 25 ml/min/1.73 m2 Ambulatory and hospitalized patients |
T2DM Elevated NT-proBNP Hospital admission for worsening HF and haemodynamically stable Patients with HFrEF administered beta-blockers and RAAS inhibitors (unless contraindicated) |
Chronic HF (NYHA class II–IV) Elevated NT-proBNP eGFR ≥ 20 ml/min/1.73 m2 |
|
HFpEF and HFrEF (LVEF < 40%) | HFpEF (LVEF > 40%) | HFpEF and HFrEF (LVEF < 50%) | HFpEF and HFrEF (LVEF < 40%) | HFpEF and HFrEF (LVEF < 40%) | |
Primary endpoints | Net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalizations, urgent heart failure visits and unplanned patient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire | Time to first occurrence of CV death, HHF or urgent HF visit |
Time to first occurrence of either CV death or HHF in patients with LVEF < 50% Time to first occurrence of either CV death or HHF in the total patient population |
Time to first event of adjudicated CV death or adjudicated HHF |
NYHA New York Heart Association, HFpEF heart failure with preserved ejection fraction, HFrEF heart failure with reduced ejection fraction, LVEF left ventricular ejection fraction, HHF hospitalization for heart failure, RAAS renin–angiotensin–aldosterone system