Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance (P-Value-AHF)
Acute Heart Failure, Diuretic Resistance
About this trial
This is an interventional treatment trial for Acute Heart Failure focused on measuring Diuretic therapy
Eligibility Criteria
Inclusion Criteria: Elective or emergency hospital admission with clinical diagnosis of acute heart failure One or more clinical signs of volume overload (i.e., peripheral edema, pleural effusion, jugular venous distension) Low diuretic efficacy in the first 2 hours after the first standard dose Furosemide i.v. (i.e., urine volume < 300 ml and urine sodium concentration < 70 mmol/L) Plasma N terminal-proBNP level at admission > 1000 ng/L Signed Informed Consent form Exclusion Criteria: Previous use of intravenous diuretics during the index hospitalization (exception first standard dose Furosemide i.v.) Maintenance treatment with Acetazolamide or Metolazone Use of any non-protocol defined diuretic agent that cannot be stopped upon study inclusion except for sodium-glucose co-transporter-2 inhibitors (e.g., dapagliflozin, empagliflozin, canagliflozin) and mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) Systolic blood pressure < 90 mmHg Expected use of intravenous vasopressors (e.g., noradrenaline, adrenaline), inotropes (e.g., dobutamine, milrinone, levosimendan) at any time point during the study Severe chronic kidney disease (estimated glomerular filtration rate < 15 ml/min/1.73 m2) or use of renal replacement therapy at any time before study inclusion Severe liver dysfunction or cirrhosis at risk of hepatic encephalopathy Severe electrolyte disturbances or metabolic acidosis requiring specific intravenous treatment Concurrent diagnosis of acute coronary syndrome requiring urgent revascularization History of cardiac transplantation or ventricular assist device Allergy, intolerance or other contraindication against one of the study drugs Pregnancy or breastfeeding Age below 18 years.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
group FF
group FM
group FA
Group FF will receive a doubled dose Furosemide i.v. The first standard dose Furosemide i.v. should be administered according to the current guidelines: (i) diuretic-naïve patients should receive Furosemide 40 mg i.v.; (ii) patients on a maintenance oral diuretic treatment should receive the equivalent dose i.v. Study medications will be used according to the prescribing information: Furosemide will be administered as an intravenous injection.
Group FM will receive a combination of standard dose Furosemide i.v. and Metolazone 5 mg p.o. The first standard dose Furosemide i.v. should be administered according to the current guidelines: (i) diuretic-naïve patients should receive Furosemide 40 mg i.v.; (ii) patients on a maintenance oral diuretic treatment should receive the equivalent dose i.v. Study medications will be used according to the prescribing information: Furosemide will be administered as an intravenous injection. Metolazone will be administered orally.
Group FA will receive a combination of standard dose Furosemide i.v. and Acetazolamide 500 mg i.v. The first standard dose Furosemide i.v. should be administered according to the current guidelines: (i) diuretic-naïve patients should receive Furosemide 40 mg i.v.; (ii) patients on a maintenance oral diuretic treatment should receive the equivalent dose i.v. Study medications will be used according to the prescribing information: Furosemide will be administered as an intravenous injection. Acetazolamide (500mg) will be administered intravenously as a short infusion.