Add-on Diuretics in Acute Decompensated Heart Failure

February 2, 2026 updated by: Dalia Abdelhamid Gomaa, Tanta University

Clinical Study Comparing Empagliflozin, Acetazolamide, and Metolazone as Add-on Therapies to Loop 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Empagliflozin group
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
Drug: empagliflozin
Empagliflozin 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
Active Comparator: Acetazolamide group
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
Drug: Acetazolamide
Acetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure
Active Comparator: Metolazone group
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
Drug: metolazone
Metolazone can augment the action of loop diuretics in patients with acute decompensated heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The cumulative urine output measured over 3 days
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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
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
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
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
3 days
30-day mortality
Time Frame: up to 30 days
Proportion of patients who die within 30 days of randomization
up to 30 days
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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Dalia A Gomaa, MSc in clinical pharmacy, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acute Heart Failure 2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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