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)
- Conditions
- patients with Acute Heart FailureMedDRA version: 20.0Level: PTClassification code 10007556Term: Cardiac failure acuteSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10066332Term: Acute cardiac insufficiencySystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2022-003206-69-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
> =18
2. Able to provide written informed consent or a legally authorized representative is able to provide written informed consent. I
3. Hospitalized for AHF, regardless of LVEF. Patients must have persistent dyspnea at rest or with mild exertion and at least one of the following signs of fluid overload : pulmonary congestion on chest X-ray or lung ultrasound; rales on chest auscultation; clinically relevant peripheral or pre-sacral edema (e.g., =1+ on a scale from 0 to 3+); or elevated jugular venous pressure.
4. Treatment with a minimum single dose of 60 mg of intravenous furosemide or equivalent intravenous loop diuretic dose (defined as 30 mg of torsemide or 1.5 mg of bumetanide)
5. Early insufficient diuretic response in patients receiving an initial loop diuretic dose >125 mg of intravenous furosemide or equivalent OR persistent insufficient diuretic response inpatients receiving an initial loop diuretic dose <125 mg of intravenous furosemide or equivalent.
Insufficient diuretic response will be assessed at 2-12 hours after the first intravenous loop diuretic dose administration, according to the recent HFA-ESC position statement on the use of diuretics in HF with congestion and to the latest 2021 ESC guidelines on the management of acute and chronic HF. An early insufficient diuretic response will be 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.
Patients who receive an initial intravenous loop diuretic starting dose =125 mg intravenous furosemide or equivalent may be enrolled in case of early insufficient diuretic response.
Conversely, patients who receive an initial intravenous loop diuretic dose <125 mg intravenous furosemide or equivalent and have an early insufficient diuretic response will have to be reassessed after 2-6 hours from the second intravenous loop diuretic dose (double dose). They will be enrolled in case of persistent insufficient diuretic response, defined as either urinary sodium <70 mEq/L at a single spot urinary sodium analysis performed 2 hours after the second intravenous loop diuretic dose (double dose) or an average urine output <150 mL/h in the 6 hours after the second intravenous loop diuretic dose (double dose). Patients with persistent insufficient diuretic response may undergo further doubling of their intravenous loop diuretic dose or combination diuretic treatment as stated in the recent guidelines.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.
7. Elevated CRP =20 mg/L according to the local laboratory, measured during the current hospitalization.
8. Eligible for randomization within the first 24 hours from presentation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
•Dyspnea due to non-cardiac causes.
•Systolic blood pressure <90 mmHg or >180 mmHg at time of screening and randomization.
•Current hospitalization for acute heart failure (AHF) primarily caused by pulmonary embolism, cerebrovascular event, or acute myocardial infarction.
•Current hospitalization for AHF not caused primarily by volume overload.
•Temperature >38.0 °C, sepsis, septic shock, or evidence of active infection (either bacterial, fungal or viral) requiring new oral or intravenous anti-microbial treatment (either antibacterial, antifungal or antiviral therapy).
•History of chronic infections, latent infections, chronic inflammatory or immunosuppressive disorders, chronic immunosuppressive therapy, ongoing chemotherapy or immunotherapy, or chronic anti-microbial therapy (either prophylactic or suppressive).
•Current treatment with intravenous corticosteroids or chronic oral corticosteroid therapy for any other condition and of any duration in the past 6 months prior to randomization.
•Documented active or history of hypocortisolism or hypercortisolism caused by primary/secondary adrenal gland disorders, pituitary disorders, iatrogenic conditions, or genetic forms.
•Decompensated diabetes mellitus.
•Acute coronary syndrome / myocardial infarction, stroke, transient ischemic attack, or intracranial bleeding in the past 90 days prior to randomization.
•Any of the following major interventions performed in the past 30 days prior to randomization or planned during the current admission: major cardiac surgery, percutaneous coronary intervention, transcatheter aortic valve replacement, or percutaneous mitral valve repair; implantation of a cardiac resynchronization therapy device; implantation of a mechanical circulatory support (MCS) device; carotid artery disease revascularization; or any other surgical procedure that is considered major” according to investigator judgement.
•Heart transplant recipient, or listed for heart transplant with expectation to receive transplant during the study period, or currently using or planned for implantation of left ventricular assist device or intra-aortic balloon pump or any other MCS device, or planned inotropic support in an outpatient setting, or planned for palliative care for HF.
•Hemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for intervention during the study period. Secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgical or percutaneous intervention during the study period.
•AHF caused by peripartum cardiomyopathy or Tako-tsubo syndrome diagnosed within the past 6 months, active myocarditis, or other acute structural heart disease.
•Cardiomyopathy due to infiltrative diseases, accumulation diseases, hypertrophic obstructive cardiomyopathy, complex congenital heart diseases, or known pericardial constriction.
•Invasive mechanical ventilation at time of screening (endotracheal intubation).
•Symptomatic ventricular tachycardia (VT) in patients without an implantable cardioverter defibrillator in the past 90 days prior to randomization.
•Symptomatic bradycardia with a documented heart rate <50 beats per minute at electrocardiogram performed before randomization or evidence of advanced atrio-ventricular block without a pacemaker.
•Atrial fibrillation/flutter with a documented, persistent resting heart rate >120 beats per minute at electrocardiogram performed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method