Add-on Diuretics in Acute Decompensated Heart Failure

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: metolazone; Drug: Acetazolamide; Drug: empagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT07372040

Acute Heart Failure 2026

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients older than 18 years.
2. 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

1. Type 1 diabetes.
2. 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.
3. A systolic blood pressure of less than 90 mmHg.
4. Cardiogenic shock.
5. Receipt of acetazolamide maintenance therapy.
6. Receipt of an SGLT2 inhibitor, thiazide, or thiazide-like diuretic in the 48 hrs before randomization.
7. Any cause of heart failure leading to decompensation that will need urgent management (eg, acute coronary syndrome, unstable arrhythmias, acute pulmonary embolism).
8. Pregnant or breastfeeding women.
9. Moderate to severe anemia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Empagliflozin group

Active Comparator group

Description:

will include 22 patients who will receive 10 mg oral empagliflozin administered simultaneously with the first dose of loop diuretics each day for 3 days

Treatment:

Drug: empagliflozin

Acetazolamide group

Active Comparator group

Description:

will include 22 patients who will receive 500 mg oral acetazolamide administered simultaneously with the first dose of loop diuretics each day for 3 days

Treatment:

Drug: Acetazolamide

Metolazone group

Active Comparator group

Description:

will include 22 patients who will receive 5 mg oral metolazone administered simultaneously with the first dose of loop diuretics each day for 3 days

Treatment:

Drug: metolazone