Amiloride hydrochloride; Furosemide for Acute heart failure

Inclusion criteria

• {"criterion_text":"- Clinical diagnosis of acute heart failure with volume overload"}
• {"criterion_text":"- ≥ 1 sign of volume overload"}
• {"criterion_text":"- Anticipated intravenous furosemide ≥ 3 days"}
• {"criterion_text":"- Age ≥ 18 years"}

Exclusion criteria

• {"criterion_text":"- Shock"}
• {"criterion_text":"- Patient requiring treatment with inotropes or vasopressors"}
• {"criterion_text":"- Current or planned use of renal replacement therapy or ultrafiltration"}
• {"criterion_text":"- Patient with a renal transplant"}
• {"criterion_text":"- Patients who are pregnant or breastfeeding"}
• {"criterion_text":"- Severe hypokalaemia (<2.5 mmol/L) or severe hyponatremia (<125 mmol/L)"}
• {"criterion_text":"- Allergy to furosemide and its components"}

Primary endpoints

• {"endpoint_text":"- Net weight loss 3 days (≈72 hours) after randomisation","definition_or_measurement_approach":"Measured as net weight loss at approximately 72 hours after randomisation (weight change from baseline to ~72 hours)."}

Secondary endpoints

• {"endpoint_text":"- Net weight loss 2 days (≈48 hours) after randomisation","definition_or_measurement_approach":"Measured as net weight loss at approximately 48 hours after randomisation."}
• {"endpoint_text":"- Change in dyspnea on a Visual Analogue Scale 3 days (≈72 hours) after randomisation","definition_or_measurement_approach":"Change in patient-reported dyspnea measured on a Visual Analogue Scale at ~72 hours after randomisation."}
• {"endpoint_text":"- Days alive out-of-hospital to Day 30","definition_or_measurement_approach":"Count of days the participant is alive and not hospitalised up to Day 30 after randomisation."}
• {"endpoint_text":"- Length of stay","definition_or_measurement_approach":"Hospital length of stay measured in days."}

Denmark

Earliest CTIS Part Ii Submission Date

13-04-2026

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

11

Number Of Sites

7

Number Of Participants

436

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"Codes: 1,8,9","organisation_type":"Educational Institution"}