NCT05809011

Efficacy and Safety of corticoSTEROids Added to Standard Therapy in Patients With Acute Heart Failure (STERO-AHF)

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)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

STERO-AHF is a pilot, prospective, multicenter, randomized, open-label, controlled clinical trial designed to evaluate the efficacy, safety and tolerability of corticosteroid therapy administered for 7 days, when added to standard therapy, in patients with acute heart failure (AHF) and evidence of insufficient diuretic response. After assessing eligibility for the study (screening period), 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. Study candidates will be adult patients who fulfill the following key inclusion criteria: 1) hospitalized with a primary diagnosis of AHF, either de novo or decompensated chronic heart failure (HF), regardless of left ventricular ejection fraction; 2) insufficient diuretic response at 2-6 hours after the first intravenous loop diuretic dose administration; 3) persistent dyspnea at rest or after mild exertion and clinical signs of fluid overload; 4) elevated C-reactive protein ≥ 10 mg/L at hospital admission. Patients with systolic blood pressure \<90 mmHg at time of screening and with severe renal impairment defined as estimated glomerular filtration rate \<20 mL/min/1.73m2 or need of chronic dialysis or temporary renal replacement therapy will be excluded from the study. After enrollment and randomization, patients assigned to corticosteroid therapy will receive it as a single-bolus intravenous injection of dexamethasone 20 mg (day 1), followed by oral prednisone 1 mg/kg daily (maximum 60 mg daily) from day 2 to day 7 after randomization. All enrolled subjects will receive standard-of-care therapy for AHF, including tailored diuretic therapy according to current management strategies for patients with insufficient diuretic response after intravenous loop diuretic dose administration. The study aim is to evaluate the diuretic efficacy and early clinical benefit of corticosteroid therapy administered for 7 days, when added to standard therapy, in diuretic-resistant patients with AHF. All randomized patients will be assessed daily while hospitalized up to day 8 or to discharge (in patients discharged earlier than day 8) or to the occurrence of death (in patients dying before day 8), and then will be followed-up at a scheduled visit at 30 days. The primary endpoints will be assessed at day 8 after randomization or at discharge (in patients discharged earlier than day 8) or at the occurrence of death (in patients dying before day 8). For the safety evaluation, all adverse events will be collected from signing of the informed consent form through day 30. The duration of enrollment will be of \~24 months. The primary completion of the study is the date when the last enrolled patient is assessed for the collection of the primary endpoint. The end of the study is the date when the last enrolled patient has completed the last follow-up visit. A total of 9 Italian high-volume, tertiary-care centers will be involved in the study. Based on sample size calculations, the trial is targeted to enroll 120 patients with AHF to provide sufficient statistical power to detect a significant difference in diuretic response (primary endpoint).

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Dexamethasone	After enrollment and randomization, the intervention (experimental arm) will be the administration of corticosteroid therapy, added to standard therapy for acute heart failure. Corticosteroid therapy will be administered as a single-bolus intravenous injection of dexamethasone 20 mg (day 1, as soon as possible after randomization), followed by oral prednisone 1 mg/kg daily (maximum 60 mg daily) from day 2 to day 7 after randomization, administered at about 8.00 AM.
DRUG	Prednisone	After enrollment and randomization, the intervention (experimental arm) will be the administration of corticosteroid therapy, added to standard therapy for acute heart failure. Corticosteroid therapy will be administered as a single-bolus intravenous injection of dexamethasone 20 mg (day 1, as soon as possible after randomization), followed by oral prednisone 1 mg/kg daily (maximum 60 mg daily) from day 2 to day 7 after randomization, administered at about 8.00 AM.

Timeline

• Start date: 2023-04-24
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2023-04-12
• Last updated: 2023-12-04

Locations

1 site across 1 country: Italy