METOLAZONE for Acute heart failure | Acute decompensated heart failure

Inclusion criteria

• {"criterion_text":"- 1.\tAged 18 years or older."}
• {"criterion_text":"- 2.\tAdmitted acutely with a clinical diagnosis of acute heart failure."}
• {"criterion_text":"- 3.\tDisplay risk of diuretic resistance, characterized by: 1.\tDaily loop-diuretics administration for a minimum of 7 days before admission, or 2.\tInsufficient decongestion observed in the preceding 24 hours (weight reduction <500g or negative fluid balance <1L) despite being treated with high-dose IV loop diuretic (equivalent to ≥120 mg IV furosemide within 24 hours)."}
• {"criterion_text":"- 4.\tClinical signs of congestion, indicated by one or more of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiological/ultrasonic evidence of pulmonary congestion."}

Exclusion criteria

• {"criterion_text":"- 1.\tAcute coronary syndrome"}
• {"criterion_text":"- 2.\tSystolic blood pressure <85 mmHg"}
• {"criterion_text":"- 3.\tUse of renal replacement therapy or ultrafiltration in-hospital before study inclusion"}
• {"criterion_text":"- 4.\tTreatment with acetazolamide or metolazone during the index hospitalization prior to randomization"}
• {"criterion_text":"- 5.\tKnown allergy to any of the used drugs"}
• {"criterion_text":"- 6.\tSevere hypokalemia (<2.5 mmol/l) or severe hyponatremia (<125 mmol/l)"}
• {"criterion_text":"- 7.\tSevere hepatic impairment defined as an INR > 1.5 (not due to anticoagulant therapy) and/or a Child-Pugh score ≥ B7"}
• {"criterion_text":"- 8.\tKnown pregnancy"}

Primary endpoints

• {"endpoint_text":"- Days alive and outside hospital until day 30","definition_or_measurement_approach":"As stated in source: 'Days alive and outside hospital until day 30'. No further definition or measurement approach provided in the available data."}

Secondary endpoints

• {"endpoint_text":"- 1.\tClinical benefit at 30 days, consisting of a composite of 1. all-cause death, 2. Readmission after discharge from initial hospitalization, 3. new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value), assessed using a Hierarchical win-ratio’ approach.","definition_or_measurement_approach":"Composite components defined in text (all-cause death; readmission; new renal-replacement therapy or persistent renal dysfunction defined as inpatient creatinine ≥200% of baseline). Assessed using a hierarchical win-ratio approach as stated."}
• {"endpoint_text":"- 2.\tDays alive and outside hospital until day 90","definition_or_measurement_approach":"As stated; no further definition provided in available data."}
• {"endpoint_text":"- 3.\tDays of admittance in the primary admission","definition_or_measurement_approach":"As stated; no further definition provided in available data."}

Denmark

Earliest CTIS Part Ii Submission Date

16-03-2024

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

752

Number Of Sites

6

Number Of Participants

939

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 12","organisation_type":"Hospital/Clinic/Other health care facility"}