Journal of the American College of Cardiology
JACC State-of-the-Art Review
Cardiac and Renal Effects of Sodium-Glucose Co-Transporter 2 Inhibitors in DiabetesJACC State-of-the-Art Review
Thomas A. Zelniker and Eugene Braunwald
Table 1
Table 1
Ongoing Cardiovascular Outcome and Heart Failure Trials Registered on ClincialTrials.gov for Canagliflozin, Dapagliflozin, Empagliflozin, and Sotagliflozin
| Drug and NCT Number | Trial Title | Trial Acronym | Estimated Enrollment (n) | Anticipated Completion Date | Duration (yrs) |
|---|---|---|---|---|---|
| Cardiovascular outcomes trials∗ in type 2 diabetes mellitus | |||||
| Dapagliflozin | |||||
| NCT01730534 | Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events | DECLARE-TIMI58 | 17,276 | 7/18/2018 | 5.2 |
| Ertugliflozin | |||||
| NCT01986881 | Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease | VERTIS CV | 8,000 | 10/31/2019 | 6.0 |
| Sotagliflozin | |||||
| NCT03315143 | Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk | SCORED | 10,500 | 3/1/2022 | 4.3 |
| Heart failure (without diabetes) | |||||
| Empagliflozin | |||||
| NCT03057951 | EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction | EMPEROR-Preserved | 4,126 | 6/1/2020 | 3.3 |
| NCT03057977 | EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction | EMPEROR-Reduced | 2,850 | 6/1/2020 | 3.2 |
| NCT03128528 | Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure | ELSI | 84 | 12/31/2019 | 2.5 |
| NCT03198585 | Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction | Empire HF | 189 | 1/1/2019 | 1.5 |
| NCT03200860 | Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure | EMPA-RESPONSE | 80 | 12/1/2019 | 2.0 |
| NCT03332212 | Mechanistic Cardiac Magnetic Resonance Study to Investigate the Effects of Empagliflozin Treatment on Cardiac Physiology and Metabolism in Patients With Heart Failure | EMPA-VISION | 86 | 3/6/2019 | 1.0 |
| NCT03448406 | Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure With Preserved Ejection Fraction (HFpEF) | EMPERIAL-Preserved | 300 | 6/7/2019 | 1.3 |
| NCT03448419 | Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure With Reduced Ejection Fraction (HFrEF) | EMPERIAL-Reduced | 300 | 6/7/2019 | 1.3 |
| NCT03485222 | Safety and Efficacy of Empagliflozin versus Placebo on Top of Guideline-directed Medical Therapy in Heart Failure Patients with Reduced Ejection Fraction without Diabetes | EMPA-TROPISM | 80 | 12/2020 | 0.5 |
| Dapagliflozin | |||||
| NCT02653482 | Effect of Dapagliflozin on Symptoms and Biomarkers in Diabetes Patients With Heart Failure | DEFINE-HF | 250 | 9/1/2018 | 2.5 |
| NCT03036124 | Evaluation of the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure | Dapa-HF | 4,500 | 12/5/2019 | 2.8 |
| Sotagliflozin | |||||
| NCT03292653 | Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Patients With Worsening Heart Failure | 81 | 1/1/2019 | 1.1 | |
| NCT03521934 | Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure | SOLOIST-WHF | 4,000 | 1/2021 | 2.5 |
| Heart failure (with diabetes) | |||||
| Empagliflozin | |||||
| NCT02932436 | Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics | EmDia | 264 | 8/1/2018 | 1.8 |
| NCT03030222 | Empagliflozin Impact on Hemodynamics in Patients With Diabetes and Heart Failure | EMBRACE-HF | 60 | 9/1/2018 | 1.2 |
| NCT03271879 | Empagliflozin Versus Placebo on the Rate of Arrhythmic Events in Heart Failure Patients | ERA-HF | 128 | 6/1/2020 | 2.3 |
| Canagliflozin | |||||
| NCT02920918 | Treatment of Diabetes in Patients With Systolic Heart Failure | 88 | 11/1/2018 | 2.1 | |
| NCT03298009 | Impact of a Short-term Treatment With Canagliflozin | Canacardia-HF | 13 | 1/1/2019 | 1.2 |
| Dapagliflozin | |||||
| NCT02397421 | Safety and Effectiveness of SGLT-2 Inhibitors in Patients With Heart Failure and Diabetes | REFORM | 56 | 8/1/2017 | 2.4 |
| NCT02956811 | Does Dapagliflozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes? | DAPA-LVH | 64 | 3/1/2019 | 2.0 |
| NCT03030235 | Dapagliflozin in Type 2 Diabetes or Pre-diabetes, and Preserved Ejection Fraction Heart Failure | PRESERVED-HF | 320 | 3/1/2019 | 2.0 |
| Ertugliflozin | |||||
| NCT03416270 | ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure | ERADICATE-HF | 36 | 3/1/2021 | 3.0 |
↵∗ Cardiovascular outcome trials study major cardiac events (MACE), the composite of nonfatal myocardial infarction, stroke, and cardiovascular death.
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