Table 3 Ongoing Trials assessing the use of SGLT2 in patients with left ventricular hypertrophy or heart failure with preserved ejection fraction
SGLT 2 Inhibitor | Trial Name; Clinical Trial Identifier | Primary Outcome Measure | Patient Populationa | Final Results |
|---|---|---|---|---|
Empagliflozin | Effects of Empagliflozin on Left Diastolic Function Compared to Usual Care in Type 2 Diabetics [EmDia]. [61] NCT02932436 | Difference in E/E’ ratio measured by echocardiography | N = 264 10 mg vs placebo Age 18–84 years HbA1C ≥ 7–10% on diabetic therapy or ≥ 7–9% diet controlled GFR > 60 ml/min | October 2017 |
Empagliflozin | SGLT2 Inhibition and Left Ventricular Mass [EMPATROPHY] [62]; NCT 02728453 | Change in ventricular mass assessed using CMRI | N = 60 25 mg vs 2-4 mg Glimepiride LVEF ≥ 45% Age ≥ 40 and < 80 years Office BP ≤ 150/95 mmHg HbA1C 6.5–9% GFR > 60 ml/min | April 2018 |
Empagliflozin | Effects of Empagliflozin on Cardiac Structure in Patients with Type 2 Diabetes [EMPA-HEART] [63] NCT02998970 | Left Ventricular Mass changes measured by CMRI at 24 weeks | N = 90 10 mg vs placebo LVEF > 30% Age ≥ 40 and ≤ 80 years HbA1C 6.5- ≤ 10% GFR > 60 ml/min | June 2017 |
Dapagliflozin | Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With Type 2 Diabetes or Pre-diabetes, and PRESERVED Ejection Fraction; [64] NCT030302235 | Changes from baseline in NTproBNP | N = 320 10 mg vs placebo LVEF ≥ 45% Age 19 to < 119 years HbA1C ≥ 5.7 - < 11% GFR < 30 ml/min | March 2019 |
Dapagliflozin | Does Dapagliflozin Regress Left Ventricular Hypertrophy in Patients with Type 2 Diabetes; [65] NCT02956911 | Left Ventricular Mass changes measured by CMRI at 52 weeks | N = 64 10 mg vs placebo LVEF ≥ 45% Age ≥ 18 and ≤ 75 years HbA1C ≥ 7 - < 10% GFR > 60 ml/min | May 2019 |