Tanta university
Tanta, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT07372040
Add-on Diuretics in Acute Decompensated Heart Failure
The aim of this study is to compare the efficacy and safety of empagliflozin, acetazolamide, and metolazone as add-on therapies to loop diuretics in patients with acute decompensated heart failure.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female patients older than 18 years.
- Hospital admission with clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload (e.g. edema, ascites confirmed by echography or pleural effusion confirmed by chest X-ray or echography).
Exclusion criteria
- Type 1 diabetes.
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m² or end-stage kidney failure with the need for chronic dialysis treatment.
- A systolic blood pressure of less than 90 mmHg.
- Cardiogenic shock.
- Receipt of acetazolamide maintenance therapy.
- Receipt of an SGLT2 inhibitor, thiazide, or thiazide-like diuretic in the 48 hrs before randomization.
- Any cause of heart failure leading to decompensation that will need urgent management (eg, acute coronary syndrome, unstable arrhythmias, acute pulmonary embolism).
- Pregnant or breastfeeding women.
- Moderate to severe anemia.
Treatment and study plan
Empagliflozin
DrugEmpagliflozin may augment the natriuretic and aquaretic actions of loop diuretics in patients with acute decompensated heart failure and it does not typically cause electrolyte disturbances and has been shown to improve outcomes in patients with heart failure
Acetazolamide
DrugAcetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure
Metolazone
DrugMetolazone can augment the action of loop diuretics in patients with acute decompensated heart failure
Primary outcomes
-
The cumulative urine output measured over 3 days
Time frame: 3 days
Secondary outcomes
-
- The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: 4 days
Blood samples will be collected at baseline and after 4 days
-
The change in serum level of Soluble suppression of tumorigenicity 2 (sST2)
Time frame: 4 days
Blood samples will be collected at baseline and after 4 days
-
The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 )
Time frame: 3 days
Urine samples will be collected at baseline and after 3 days
-
The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7)
Time frame: 3 days
Urine samples will be collected at baseline and after 3 days
-
30-day mortality
Time frame: up to 30 days
Proportion of patients who die within 30 days of randomization
-
Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy
Time frame: 3 days
the treating physician will calculate the congestion score, on a scale from 0 to 10 on the basis of the sum of scores for the degree of edema (0 to 4), pleural effusion (0 to 3), and ascites (0 to 3), with higher scores indicating a worse condition on all scales
Study contacts
Contact information is provided by the study sponsor or research team.
Dalia A Gomaa, MSc in clinical pharmacy
CONTACT
+20+01063410525
Dalia R El-Afify, Associate professor
CONTACT
+20+01006831093
Sponsors and collaborators
Lead sponsor
Tanta University
Other
Registry information
Official study title
Clinical Study Comparing Empagliflozin, Acetazolamide, and Metolazone as Add-on Therapies to Loop Diuretics in Acute Decompensated Heart Failure
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 28, 2026
- Registry last updated
- Feb 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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