Table 2.
Clinical trials of SGLT2 inhibitors on T2D patients with HFrEF, HFmrEF, or HFpEF.
| SGLT2 inhibitors (year of reporting) | Trial design |
Participants |
Primary outcomes/ endpoints | Follow-up (average, months) | Population |
Reference |
|---|---|---|---|---|---|---|
| T2D with/without established CVD | ||||||
| Empagliflozin | EMPA-REG OUTCOME (NCT 01131676) | T2D with established CVD | CVD death/nonfatal MI/nonfatal stroke | 37 | n = 7020; mean age: 63.1 | Zinman et al. (2015) |
| Canagliflozin | CANVAS (NCT 01032629) | T2D with established CVD or multiple risk factors for CVD | CVD death/nonfatal MI/nonfatal stroke | 47.2 | n = 10142; mean age: 63.3 | Neal et al. (2017) |
| Dapagliflozin | DECLARE–TIMI 58 (NCT 01730534) | T2D with established CVD or multiple risk factors for CVD | MACE/CVD/HFH | 50 | n = 17160; mean age: 63.9 | Wiviott et al. (2019) |
| LVEF ≤ 40% (HFrEF) with or without T2D | ||||||
| Dapagliflozin | DAPA-HF (NCT 03036124) | LVEF ≤ 40% with or without T2D | HFH/CVD | 18.2 | n = 4744; mean age: 66.3 | Neal et al. (2017) |
| Empagliflozin | EMPEROR-reduced (NCT 03057977) | LVEF ≤ 40% with or without T2D | HFH/CVD | 16 | n = 3730; mean age: 66.8 | Packer et al. (2020) |
| Empagliflozin | EMPERIAL-reduced (NCT 03448419) | LVEF ≤ 40% with or without T2D | 6 MWTD changed | 3 | n = 312; mean age: 69.0 | Abraham et al. (2021) |
| LVEF < 50% (40%–49%, HFmrEF) with or without T2D | ||||||
| Empagliflozin | EMPERIAL- preserved (NCT 03448406) | LVEF < 40% with or without T2D | 6 MWTD changed | 3 | n = 315; mean age: 73.5 | Abraham et al. (2021) |
| Empagliflozin | EMPATROPISM (NCT 03485222) | LVEF < 50% without T2D | Evaluated by cardiac magnetic resonance imaging of changes in LVEDV and LVESV | 6 | n = 84; mean age: 62.0 | Santos-Gallego et al. (2021) |
| Sotagliflozin | SOLOIST-WHF (NCT 03521934) | LVEF < 50% with or without T2D | CVD death/HFH | 9 | n = 966; mean age: 69.0 | Bhatt et al. (2021) |
| LVEF ≥ 50% (HFpEF) with or without T2D | ||||||
| Sotagliflozin | SOLOIST-WHF (NCT 03521934) | LVEF ≥ 50% with or without T2D | CVD death/HFH | 9 | n = 256; mean age: 69.0 | Bhatt et al. (2021) |
| Dapagliflozin | PRESERVED-HF (NCT 03485222) | LVEF ≥ 60% with or without T2D | KCCQ-CS | 3 | n = 324; mean age: 70.0 | Nassif et al. (2021) |
CANVAS, Canagliflozin Cardiovascular Assessment Study; DAPA-HF, Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure; ECLARE–TIMI 58, Effect on Cardiovascular Events–Thrombolysis in Myocardial Infarction 58; EMPA-REG OUTCOME, Empagliflozin Cardiovascular Outcome Event Trial; EMPERIAL-Preserved, Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction; EMPERIAL-Reduced, Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Reduced Ejection Fraction; KCCQ-CS, Kansas City Cardiomyopathy Questionnaire Clinical Summary Score; LVEDV, LV end-diastolic volume; MACE, major adverse cardiovascular event; 6 MWTD, 6-minute walk test distance.