Empagliflozin in Acute Heart Failure

Korábbi kezelés

• use within the last 48 h of an SGLT-2 inhibitor or a combined SGLT-1 and SGLT-2 inhibitor
• maintenance dialysis or need for emergent renal replacement therapy

Más betegség

• history of type 1 diabetes mellitus
• known hypersensitivity to SGLT-2 inhibitors
• gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
• recurrent severe genital or urinary tract infection
• any other clinical condition that would jeopardize patient safety while participating in this trial

Laborértékek

• liver disease defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
• Patients with an acute rise in creatinine levels (acute cardiorenal syndrome) upon presentation will not be excluded.

Egyéb

• new use of a non-loop diuretic other than an MRA
• euglycemic diabetic ketoacidosis
• pregnancy or breastfeeding

• moderate to advanced CKD, defined as an eGFR <45 ml/min/1.73m2; The average creatinine values over the last 12 months will be used to calculate baseline eGFR.
• acutely decompensated heart failure, defined as dyspnea at rest or with minimal physical activity, associated with at least one clinical sign of congestion and at least one objective measure of heart failure (pulmonary-capillary wedge pressure >20 mm Hg or evidence of pulmonary congestion on chest radiography or brain natriuretic peptide (BNP) level ≥400 pg/ml or N-terminal pro-BNP level ≥1000 pg/ml);
• evidence of inadequate response to loop diuretics, defined as a urine output < 1000 ml/24h or a weight loss < 1kg /24h. For patients who have not received loop diuretics, a furosemide stress test can be conducted.
• stable hemodynamics, defined as systolic blood pressure >90 mmHg and/or mean arterial pressure >65 mmHg in the absence of intravenous norepinephrine or epinephrine in the last 24 hours.