A Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of corticoSTEROids Added to Standard Therapy in Patients With Acute Heart Failure (STERO-AHF)
STERO-AHF is a pilot, prospective, multicenter, randomized, open-label, controlled study aimed to evaluate the diuretic efficacy and early clinical benefit of corticosteroid therapy administered for 7 days, in addition to standard therapy, in patients hospitalized for acute heart failure (AHF) and with evidence of insufficient diuretic response. Eligible patients will be randomized 1:1 to receive either standard-of-care alone (control group) or standard-of-care plus corticosteroid therapy (experimental group) for up to 7 days. Patients will be followed to 30 days.
• Full age of consent at screening (at least ≥18 years old according to local legislation).
• Able to provide written informed consent or a legally authorized representative is able to provide written informed consent.
• Hospitalized for AHF, either de novo or decompensated chronic HF, regardless of LVEF.
• Treatment with a minimum single dose of 40 mg of intravenous furosemide or equivalent intravenous loop diuretic dose (defined as 20 mg of torsemide or 1 mg of bumetanide) at any time between presentation and the end of screening.
• Insufficient diuretic response assessed at 2-6 hours after the first intravenous loop diuretic dose administration, according to the latest 2021 ESC guidelines on the management of acute and chronic HF, defined as either urinary sodium \<70 mEq/L at a single spot urinary sodium analysis performed at 2 hours or an average urine output \<150 mL/h in the first 6 hours after first intravenous diuretic administration. In case of early insufficient diuretic response and persistence of congestion, the dose of intravenous loop diuretic will have to be doubled and the patient may be enrolled.
• New York Heart Association functional class II, III or IV at screening.
• Elevated NT-proBNP ≥1400 pg/mL or BNP ≥350 pg/mL according to the local laboratory for patients without atrial fibrillation, or NT-proBNP ≥2200 pg/mL or BNP ≥550 pg/mL for patients with atrial fibrillation at the time of admission and/or in the 72 hours prior to hospital admission.
• Elevated CRP ≥10 mg/L according to the local laboratory, measured during the current hospitalization.
• Eligible for randomization within the first 24 hours from presentation.