Table 2 Ongoing trials assessing the use of SGLT2 inhibitors in patients with systolic heart failure
SGLT2 Inhibitor | Trial Name; Clinical Trial Identifier | Primary Outcome measure | Patient Populationa | Final Results |
|---|---|---|---|---|
Empagliflozin | Empagliflozin Impact on Haemodynamics in Patients with Diabetes and Heart Failure [EMBRACE-HF]. [54] NCT03030222 | Change in pulmonary artery diastolic pressure | N = 60 10 mg vs placebo Either LVEF 40% or > 40% NHYA II-IV HbA1c ≥ 6.5% and ≤ 11% GFR > 30 ml/min | June 2018 |
Empagliflozin | SGLT2 Inhibition in Diabetic Patients With Heart Failure with Reduced Ejection Fraction [55] NCT02862067 | SGLT2 inhibition effects on cardiorespiratory fitness | N = 31 10 mg/25 mg standard care LVEF ≤ 50% [in maximum tolerated HF therapy HbA1c 7–10% Age ≥ 18 years GFR > 45 ml/min | June 2018 |
Empagliflozin | EMPagliflozin outcomE tRial in Patients with chrOnic heaRt Failure with Reduced Ejection Fraction [EMPEROR-Reduced] [56] NCT03057977 | Time to first event of adjudicated CV death or adjudicated hospitalisation for HF in patients with HF with reduced ejection fraction | N = 2850 LVEF ≥ 36to ≤ 40%: NTproBNP ≥ 2500 pg/ml LVEF ≥ 31% to ≤ 35%: NT-proBNP ≥ 1000 pg/ml If LVEF ≤ 30% NT-proBNP ≥ 600 pg/ml Age > 18 years GFR > 20 ml/min | June 2020 |
Dapagliflozin | Dapagliflozin Effect on Symptoms and Biomarkers in Diabetes Patients with Heart Failure [DEFINE-HF] [57] NCT02653482 | Differences in the average reduction of NTproBNP Proportion of patient that achieve a ≥ 5pts increase in heart failure disease specific quality of life score or a ≥ 20% decrease in NTproBNP | N = 250 10 mg vs placebo LVEF ≤ 40/NHYA II-III HbA1c 6.5–11.0% Age 19–119 years GFR > 45 ml/min BNP ≥ 125 pg/ml and/or NTproBNP ≥ 600 pg/ml | May 2017 |
Dapagliflozin | Study to Evaluate the Effect of dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction [Dapa-HF]. [58] NCT03036124 | Time to first occurrence of the composite: CV death or hospitalisation for HF or urgent HF visit. | N = 4500 5/10 mg vs placebo LVEF ≤ 40/NHYA II-IV Age 18 to 130 years GFR > 30 ml/min NTproBNP ≥ 600 pg/ml | December 2019 |
Dapagliflozin | Safety and Effectiveness of SGLT2 inhibitors in Patients with Heart Failure and Diabetes [REFORM] [59] NCT02397421 | Change in LV end systolic volume or LV end diastolic volume as determined by CMRI | N = 56 10 mg vs placebo. LVEF < 50%/NYHA I-II HbA1c > 6% Age 18 to 75 years GFR > 45 ml/min | August 2017 |
Canagliflozin | A Randomised Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients with Systolic Heart Failure. [60] NCT02920918 | Change from baseline aerobic exercise capacity Change from baseline ventilator efficiency | N = 88 LVEF ≤ 40%/NYHAII-III HbA1C 6.5%–10% Age ≥ 18 years GFR >50 ml/min | November 2018 |