Actively Recruiting
Clinical Study Comparing Empagliflozin, Acetazolamide, and Metolazone as Add-on Therapies to Loop Diuretics in Acute Decompensated Heart Failure
Led by Tanta University · Updated on 2026-02-04
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness and safety of three add-on drugs—empagliflozin, acetazolamide, and metolazone—when given with loop diuretics to patients hospitalized with acute decompensated heart failure. This phase 2 clinical trial aims to understand which of these treatments best supports fluid removal and heart failure management in this patient group. The study includes three groups of 22 patients each. One group receives 10 mg of empagliflozin, another 500 mg of acetazolamide, and the third 5 mg of metolazone. Each drug is given orally alongside the first dose of loop diuretics daily for three days. The trial does not use placebos and participants are randomly assigned to one of the three treatment groups. Participants will be closely monitored during the three-day treatment period with measurements such as total urine output and changes in specific blood and urine biomarkers related to heart failure. Researchers will also track 30-day mortality rates and assess treatment effectiveness using the ADVOR Score. This monitoring helps evaluate the safety and impact of these add-on therapies over the short term and up to 30 days after treatment begins.
CONDITIONS
Brief Title
Add-on Diuretics in Acute Decompensated Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients older than 18 years
- Hospital admission with clinical diagnosis of acute decompensated heart failure
- Presence of at least one clinical sign of volume overload such as edema, ascites confirmed by echography, or pleural effusion confirmed by chest X-ray or echography
You will not qualify if you...
- Diagnosis of type 1 diabetes
- Chronic kidney disease with eGFR less than 30 mL/min per 1.73 m² or end-stage kidney failure requiring chronic dialysis
- Systolic blood pressure below 90 mmHg
- Presence of cardiogenic shock
- Current maintenance therapy with acetazolamide
- Use of SGLT2 inhibitors, thiazide, or thiazide-like diuretics within 48 hours before randomization
- Heart failure caused by urgent conditions needing immediate treatment (e.g., acute coronary syndrome, unstable arrhythmias, acute pulmonary embolism)
- Pregnant or breastfeeding women
- Moderate to severe anemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive one of three add-on therapies (empagliflozin, acetazolamide, or metolazone) alongside loop diuretics to manage acute decompensated heart failure.
Daily dosing with 3 visits (in-person)
Duration - Up to 30 days
Participants are monitored for outcomes including changes in biomarkers and 30-day mortality after treatment completion.
Follow-up assessments within 30 days after treatment
Trial Site Locations
Total: 1 location
1
Tanta university
Tanta, Egypt
Actively Recruiting
Research Team
D
Dalia A Gomaa, MSc in clinical pharmacy
D
Dalia R El-Afify, Associate professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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