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RecruitingNCT07372040Updated Feb 4, 2026

Add-on Diuretics in Acute Decompensated Heart Failure

A Phase 2 interventional study of empagliflozin and Acetazolamide in Acute Decompensated Heart Failure, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Decompensated Heart Failure

Keywords

  • Empagliflozin
  • Acetazolamide
  • Metolazone
  • Acute heart failure
  • Add-on therapies to Loop diuretics
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Drugempagliflozin

    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

  • DrugAcetazolamide

    Acetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure

  • Drugmetolazone

    Metolazone can augment the action of loop diuretics in patients with acute decompensated heart failure

06

What researchers measure

Primary outcomes

  1. The cumulative urine output measured over 3 days

    Time frame: 3 days

Secondary outcomes

  1. - The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP)

    Blood samples will be collected at baseline and after 4 days

    Time frame: 4 days

  2. The change in serum level of Soluble suppression of tumorigenicity 2 (sST2)

    Blood samples will be collected at baseline and after 4 days

    Time frame: 4 days

  3. The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 )

    Urine samples will be collected at baseline and after 3 days

    Time frame: 3 days

  4. The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7)

    Urine samples will be collected at baseline and after 3 days

    Time frame: 3 days

  5. 30-day mortality

    Proportion of patients who die within 30 days of randomization

    Time frame: up to 30 days

  6. Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy

    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

    Time frame: 3 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07372040
Lead sponsor
Tanta University
Responsible party
Dalia Abdelhamid Gomaa (assistant lecturer of clinical pharmacy, faculty of pharmacy, Tanta University) — Principal investigator
First posted
Jan 28, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Feb 4, 2026

Study contacts

Dalia A Gomaa, MSc in clinical pharmacy
Contact
dalia_gomaa@pharm.tanta.edu.eg
+20+01063410525
Dalia R El-Afify, Associate professor
Contact
dalia.mohamed1@pharm.tanta.edu.eg
+20+01006831093
Dalia A Gomaa, MSc in clinical pharmacy
principal investigator · Tanta University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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