Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction

Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction: A Randomized Clinical Trial (Empire HF)

To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction.

The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).

Inclusion Criteria:

• Optimal Heart Failure Therapy in accordance with European and National Guidelines
• LVEF ≤ 0.40
• eGFR > 30 ml/min/1.73 m2
• BMI < 45 kg/m2
• NYHA class I-III
• Age > 18 years
• If T2D - optimal treatment in accordance with European and National Guidelines
• If T2D - stable doses of antiglycemic treatment for 30 days
• If T2D - HbA1C 6.5-10%

Exclusion Criteria:

• CRT-D/-P implanted < 90 days
• Uncorrected severe valvular disease
• Non-compliance
• Use of metalozone
• NYHA IV
• Age > 85 years
• Dementia
• Admission for HF < 30 days
• Admission for hypoglycemia < 12 month
• Known sustained VT
• Symptomatic hypotension and systolic BP < 95 mmHg
• Unable to perform an exercise test
• Immobilization
• Pregnancy
• Participation in other medical trials
• Previous intolerance of Empagliflozin or excipients