Cardiovascular outcome trials have shown considerable improvement in heart failure hospitalisation and other cardiovascular outcomes in people using sodium-glucose co-transporter-2 (SGLT-2) inhibitors. |
There are currently no treatments demonstrating mortality benefit for people with heart failure and preserved ejection fraction (HFpEF). |
The EMPEROR trials will considerably add to our understanding of the future role for SGLT-2 inhibitors in people with heart failure, particularly HFpEF. |
Planned sub-analyses of the EMPEROR trials, which include analyses of changes in renal function and incident diabetes, will also be of particular interest. |
Introduction
Cardiovascular Outcome Trials and Sodium-Glucose Co-Transporter-2 Inhibitors: Key Cardiovascular and Heart Failure Outcomes
Established Heart Failure Therapies Improve Mortality in HFrEF but not HFpEF
Rationale for SGLT-2 Inhibitors in Heart Failure
Study Overview: The Emperor-Reduced and Emperor-Preserved Trials
Inclusion/exclusion criteria | EMPEROR-reduced trial | EMPEROR-preserved trial |
---|---|---|
Inclusion criteria | • Aged ≥ 18 years • Patients with chronic heart failure (≥ 3 months), NYHA class II-IV and reduced LVEF ≤ 40% with elevated NT-proBNP: - If EF = 36–40%: NT-proBNP ≥ 2500 pg/ml for patients without AF; NT-proBNP ≥ 5000 pg/ml for patients with AF - If EF = 31–35%: NT-proBNP ≥ 1000 pg/ml for patients without AF; NT-proBNP ≥ 2000 pg/ml for patients with AF - If EF ≤ 30%: NT-proBNP ≥ 600 pg/ml for patients without AF; NT-proBNP ≥ 1200 pg/ml for patients with AF - If EF ≤ 40% and HHF < 12 months: NTproBNP ≥ 600 pg/ml for patients without AF; NT-proBNP ≥ 1200 pg/ml with AF • Appropriate medical therapy for HF, stable for at least 1 week • Appropriate use of medical devices, such as ICD or CRT | • Aged ≥ 18 years • Patients with chronic heart failure (≥ 3 months), NYHA class II-IV and preserved LVEF > 40% with elevated NT-proBNP: - NT-proBNP > 300 pg/ml for patients without AF - NT-proBNP > 900 pg/ml for patients with AF • Structural heart disease within 6 months prior, or documented HHF within 12 months prior to Visit 1 • Stable dose of oral diuretics, if prescribed |
Exclusion criteria (same in both trials) | • Myocardial infarction, CABG or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1 • Heart transplant recipient, or listed for heart transplant • Acute decompensated HF • Systolic blood pressure (SBP) ≥ 180 mmHg, symptomatic hypotension and/or SBP ≤ 100 mmHg • Indication of liver disease • eGFR < 20 ml/min/1.73 m2 or requiring dialysis • History of ketoacidosis • Current use or prior use of a SGLT-2 inhibitor • Currently enrolled in an investigational device or drug study • Known hypersensitivity to empagliflozin or SGLT-2 inhibitor • Women who are pregnant, or who plan to become pregnant |