Comparing the efficacy of empagliflozin versus dapagliflozin in the treatment of patients hospitalized with acute decompensated heart failure: A randomized active-controlled clinical trial
The study is conducted in the coronary care unit (CCU) and other cardiac wards, with patient screening in the emergency department and inpatient wards. Daily fluid intake, weight, and urine output are recorded. N-terminal pro-B-type natriuretic peptide (NT-proBNP) is measured at baseline and before discharge or on day 5. Spot urine electrolytes are measured at baseline and day 3. Congestion is assessed using the orthoedema scale at study start and end.
Participants/Inclusion and exclusion criteria
Patients aged ≥18 years with hypervolemic ADHF and an estimated glomerular filtration rate (eGFR) >25 mL/min/1.73 m² are eligible. Exclusion criteria include serum glucose <70 mg/dL, type 1 diabetes, history of diabetic ketoacidosis (DKA), systolic blood pressure <90 mmHg, severe aortic or mitral stenosis, and acute coronary syndrome (ACS).
Intervention groups
Empagliflozin 10 mg once daily vs. dapagliflozin 10 mg once daily, both added to standard therapy.
Main outcome variables
The primary outcome is reduction in body weight at the end of the in-study period. Secondary Outcomes are 30-day mortality, 30-day readmission, change in NT-proBNP, and natriuresis measures. Safety outcomes include the incidence of acute kidney injury (AKI).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240924063144N1
Registration date:2026-06-13, 1405/03/23
Registration timing:registered_while_recruiting
Last update:2026-06-13, 1405/03/23
Update count:0
Registration date
2026-06-13, 1405/03/23
Registrant information
Name
Kasra Morad Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6601 8941
Email address
kasraa.ms@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-09-20, 1405/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of empagliflozin versus dapagliflozin in the treatment of patients hospitalized with acute decompensated heart failure: A randomized active-controlled clinical trial
Public title
Randomized clinical trial of empagliflozin vs dapagliflozin in acute decompensated heart failure.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of institute of pharmaceutical sciences - Tehran university of medical sci
Street address
Central Building of Tehran University of Medical Sciences, 6th Floor, Room 604, Keshavarz Blvd., Quds St. Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2024-12-02, 1403/09/12
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.164
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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))
2
Description
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.
3
Description
Reducing the need to use inotropes.
Timepoint
Measured daily.
Method of measurement
Through the patient's file.
4
Description
Reducing the need to use vasopressors.
Timepoint
Measured daily.
Method of measurement
Through the patient's file.
5
Description
Reducing the need to add a second diuretic to the diuretic regimen.
Timepoint
Measured daily.
Method of measurement
Through the patient's file.
6
Description
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.
7
Description
Serum creatinine changes.
Timepoint
Measured daily.
Method of measurement
Lab test.
8
Description
Urine output changes.
Timepoint
Measured daily.
Method of measurement
Using urinary bag or collection container.
9
Description
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.
10
Description
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
11
Description
Reducing the need for hemodialysis.
Timepoint
If hemodialysis is performed.
Method of measurement
Through the patient file.
12
Description
Reducing 30-day mortality.
Timepoint
30 days after hospital discharge.
Method of measurement
Via telephone and medical record review.
13
Description
Reducing 30-day rehospitalization.
Timepoint
30 days after hospital discharge.
Method of measurement
Via telephone and medical record review.
14
Description
Reducing the length of hospital stay.
Timepoint
Measured as days from admission to discharge.
Method of measurement
Measured as days from admission to discharge.
15
Description
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.
16
Description
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.
17
Description
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.
Intervention groups
1
Description
Intervention group 1: Empagliflozin 10 mg tablet from Actoverco Pharmaceutical Company, 1 tablet daily for 30 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: Dapagliflozin 10 mg tablet from Actoverco Pharmaceutical Company, 1 tablet daily for 30 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Keyhan Mohammadi
Street address
At the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 0033
Fax
+98 21 6658 1625
Email
Imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Keyhan Mohammadi
Street address
Deputy of Research and Technology, 6th Floor, corner of Ghods Street, Central Office of the University, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8889 6690
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Keyhan Mohammadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy (Pharmacotherapy)
Street address
Keshavarz Boulevard, Imam Khomeini Hospital Complex, Pharmaceutical Care Department
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
Keyhanmohammadi72@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Keyhan Mohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacotherpy
Street address
Pharmaceutical Care Department, Valiasr Hospital, Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
keyhanmohammadi72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kasra Morad Soltani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Clinical Pharmacy (Pharmacotherapy)
Street address
Keshavarz Boulevard, Imam Khomeini Hospital Complex, Pharmaceutical Care Department
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
kasraa.ms@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available