NCT07372040

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
9mo left

Started Feb 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

January 19, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 19, 2026

Last Update Submit

February 2, 2026

Conditions

Acute Decompensated Heart Failure

Keywords

EmpagliflozinAcetazolamideMetolazoneAcute heart failureAdd-on therapies to Loop diuretics

Outcome Measures

Primary Outcomes (1)

  • The cumulative urine output measured over 3 days

    3 days

Secondary Outcomes (6)

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

    4 days

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

    4 days

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

    3 days

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

    3 days

  • 30-day mortality

    up to 30 days

  • +1 more secondary outcomes

Study Arms (3)

Empagliflozin group

ACTIVE COMPARATOR

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

Acetazolamide group

ACTIVE COMPARATOR

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

Metolazone group

ACTIVE COMPARATOR

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

metolazoneDRUG

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

Metolazone group
empagliflozinDRUG

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

Empagliflozin group
AcetazolamideDRUG

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

Acetazolamide group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients older than 18 years.
  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university

Tanta, Egypt

RECRUITING

MeSH Terms

Interventions

empagliflozinAcetazolamideMetolazone

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesSulfonesQuinazolinonesQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Dalia A Gomaa, MSc in clinical pharmacy

    Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia A Gomaa, MSc in clinical pharmacy

CONTACT

+20+01063410525dalia_gomaa@pharm.tanta.edu.eg

Dalia R El-Afify, Associate professor

CONTACT

+20+01006831093dalia.mohamed1@pharm.tanta.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of clinical pharmacy, faculty of pharmacy

Study Record Dates

First Submitted

January 19, 2026

First Posted

January 28, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)