Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05809011
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-03-19
Brief Title:
Efficacy and Safety of corticoSTEROids Added to Standard Therapy in Patients With Acute Heart Failure STERO-AHF
Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Organization:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STERO-AHF
Brief 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 11 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 11 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 mgL 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 mLmin173m2 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 mgkg 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
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 mgL 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 mLmin173m2 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 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-003206-69 | EUDRACT_NUMBER | None | None |