Adding extra diuretics to standard care for acute decompensated heart failure

Clinical Study Comparing Empagliflozin, Acetazolamide, and Metolazone as Add-on Therapies to Loop Diuretics in Acute Decompensated Heart Failure

This trial will test whether adding empagliflozin, acetazolamide, or metolazone to loop diuretics helps adults hospitalized with acute decompensated heart failure remove fluid and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tanta University (other)
• Locations: 1 site (Tanta)
• Trial ID: NCT07372040 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study compares three different add-on diuretic strategies—empagliflozin, acetazolamide, and metolazone—given alongside loop diuretics in adults admitted with acute decompensated heart failure and signs of volume overload. Eligible hospitalized patients will be assigned one of the three add-on therapies and monitored for decongestion, kidney function, blood pressure, and adverse events. Key exclusions include type 1 diabetes, severe renal impairment (eGFR <30 mL/min/1.73 m2), cardiogenic shock, very low systolic blood pressure, recent use of SGLT2 or thiazide(-like) diuretics, and pregnancy. The trial is conducted at Tanta University and focuses on short-term efficacy and safety outcomes during hospitalization.

Who should consider this trial

Good fit: Adults over 18 years old who are hospitalized with acute decompensated heart failure and at least one sign of volume overload, who do not have severe kidney failure, cardiogenic shock, very low blood pressure, or recent use of the study drug classes, are ideal candidates.

Not a fit: Patients with type 1 diabetes, end-stage renal disease or eGFR <30 mL/min/1.73 m2, cardiogenic shock, systolic blood pressure under 90 mmHg, recent use of SGLT2 or thiazide(-like) diuretics, or those who are pregnant or breastfeeding are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the interventions could speed fluid removal, improve symptoms, and reduce complications of volume overload during hospitalization.

How similar studies have performed: Other work has shown that adding agents like acetazolamide can improve decongestion in acute heart failure and that SGLT2 inhibitors improve outcomes in heart failure overall, while metolazone is commonly used as an add-on despite more limited randomized data.

Eligibility criteria

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.

Where this trial is running

Tanta

• Tanta university — Tanta, Egypt (RECRUITING)

Study contacts

• Principal investigator: Dalia A Gomaa, MSc in clinical pharmacy — Tanta University
• Study coordinator: Dalia A Gomaa, MSc in clinical pharmacy

Conditions: Acute Decompensated Heart Failure, Empagliflozin, Acetazolamide, Metolazone, Acute heart failure, Add-on therapies to Loop diuretics