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IRCT20240924063144N1 IRCT 2026-06-13 Tehran University of Medical Sciences Randomized clinical trial of empagliflozin vs dapagliflozin in acute decompensated heart failure. Comparing the efficacy of empagliflozin versus dapagliflozin in the treatment of patients hospitalized with acute decompensated heart failure: A randomized active-controlled clinical trial 2026-05-22 anticipated 140 Recruiting https://irct.ir/trial/79242 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized to one of two groups: empagliflozin or dapagliflozin, using the block randomization size 4 method. Randomization will be based on a 1:1 ratio. 3 Heart failure. Intervention 1: Intervention group 1: Empagliflozin 10 mg tablet from Actoverco Pharmaceutical Company, 1 tablet daily for 30 days. Intervention 2: Intervention group 2: Dapagliflozin 10 mg tablet from Actoverco Pharmaceutical Company, 1 tablet daily for 30 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Keyhan Mohammadi
Keshavarz Boulevard, Imam Khomeini Hospital Complex, Pharmaceutical Care Department
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1692 Keyhanmohammadi72@yahoo.com Tehran University of Medical Sciences scientific Keyhan Mohammadi
Pharmaceutical Care Department, Valiasr Hospital, Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1692 keyhanmohammadi72@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age of 18 years or older Hospitalized for acute decompensated heart failure, defined as all of the following: (i) dyspnea at rest or with minimal exertion, (ii) signs of congestion, such as edema, rales, and/or congestion on chest radiograph, (iii) N-terminal pro BNP (NT-proBNP) ≥ 1400 pg/mL (for patients with atrial fibrillation: NT-proBNP ≥ 2000 pg/mL) Patients should be randomized within 24 hours and up to 5 days after hospitalization, as soon as possible after hemodynamic stabilization. Patients should have received at least one dose of intravenous furosemide at the time of screening. Patients should meet the following criteria for hemodynamic stabilization: (i) SBP ≥90 mm Hg and no signs of hypotension in the previous 6 hours (ii) Not receiving intravenous vasodilators in 6 hours before randomization (iii) Not receiving intravenous inotropes in 24 hours before randomization Consent to enter the study 18 years no limit Both Participation in other interventional clinical studies Serum glucose <70 mg/dL Type 1 diabetes History of hypersensitivity to any SGLT-2 inhibitors Women who are pregnant or breastfeeding Severe anemia (Hemoglobin <7 g/dL) Severe valvular disorders (Aortic stenosis and severe Mitral stenosis recognized based on guideline definitions and echocardiographic findings) and not associated with acute heart failure Severe hepatic impairment (Child-Pugh class C) Hospitalization due to acute coronary syndrome Shortness of breath (dyspnea) due to non-cardiac causes Cardiogenic shock Active urinary tract infection at the beginning of the study History of diabetic ketoacidosis and/or Hyperosmolar hyperglycemic state (pH < 7.30 and Plasma Glucose > 250 mg/dL and HCO3 < 18 mEq/L) Type 2 diabetic patients who receive high doses of insulin (more than 2 units/kg/day). eGFR <25 ml/min/1.73m2 I50 Heart failure Treatment - Drugs Treatment - Drugs Intervention group 1: Empagliflozin 10 mg tablet from Actoverco Pharmaceutical Company, 1 tablet daily for 30 days. Intervention group 2: Dapagliflozin 10 mg tablet from Actoverco Pharmaceutical Company, 1 tablet daily for 30 days. Weight reduction at the end of the study. Timepoint: Measuring the patient's weight at the beginning of the study and then daily for 5 days or until discharge (whichever happens earlier). Method of measurement: via weighing scale. Furosemide efficacy. Timepoint: At the end of the study (day 5) or discharge, whichever occurs first. Method of measurement: (Weight on the fifth day - Weight on the first day)/((total dose of intravenous furosemide)/(40 mg) + (total dose of oral furosemide)/(80 mg)). Furosemide dose reduction. Timepoint: The cumulative dose of furosemide (sum of intravenous and oral doses) will be measured daily and at the end of the study. Method of measurement: Through the dose registration sheet. Reducing the need to use inotropes. Timepoint: Measured daily. Method of measurement: Through the patient's file. Reducing the need to use vasopressors. Timepoint: Measured daily. Method of measurement: Through the patient's file. Reducing the need to add a second diuretic to the diuretic regimen. Timepoint: Measured daily. Method of measurement: Through the patient's file. NT-proBNP changes. Timepoint: Measured at enrollment of the study and on day five of the study or discharge, whichever occurs first. Method of measurement: Lab test. Serum creatinine changes. Timepoint: Measured daily. Method of measurement: Lab test. Urine output changes. Timepoint: Measured daily. Method of measurement: Using urinary bag or collection container. Orthoedema scale changes. Timepoint: Measured at the baseline and on day five of the study or the day of hospital discharge (whichever occurs first). Method of measurement: Using the Orthoedema scale. Fractional Excretion of Sodium (FENa) changes. Timepoint: Spot urine electrolytes will be measured at the patient's hospital admission and within 6 hours of receiving the IV furosemide dose, and also on the third day after receiving the studied medications. Method of measurement: Using a spot urine sample and measuring the level of its electrolytes. Reducing the need for hemodialysis. Timepoint: If hemodialysis is performed. Method of measurement: Through the patient file. Reducing 30-day mortality. Timepoint: 30 days after hospital discharge. Method of measurement: Via telephone and medical record review. Reducing 30-day rehospitalization. Timepoint: 30 days after hospital discharge. Method of measurement: Via telephone and medical record review. Reducing the length of hospital stay. Timepoint: Measured as days from admission to discharge. Method of measurement: Measured as days from admission to discharge. Incidence of acute kidney failure(AKI). Timepoint: Evaluated daily. Method of measurement: Based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria and through the monitoring of the patient's urine volume and serum creatinine. Incidence of Diabetic ketoacidosis. Timepoint: Evaluated daily. Method of measurement: Through monitoring venous blood gas, the presence of ketones in the urine sample, and the patient's blood sugar. Incidence of urinary tract infection. Timepoint: Assessed daily for symptoms suggestive of urinary tract infection. Method of measurement: Based on the treating physician's examination and history. Tehran University of Medical Sciences Approved 2024-12-02 Research ethics committee of institute of pharmaceutical sciences - Tehran university of medical sci Central Building of Tehran University of Medical Sciences, 6th Floor, Room 604, Keshavarz Blvd., Quds St. Intersection, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)