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Recruiting NCT07372040

Add-on Diuretics in Acute Decompensated Heart Failure

Phase II Interventional Acute Decompensated Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: empagliflozin, Acetazolamide, metolazone.
Who it may be relevant to
Registry conditions: Acute Decompensated Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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
  • Drug Acetazolamide
    Acetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure
  • Drug metolazone
    Metolazone can augment the action of loop diuretics in patients with acute decompensated heart failure

Primary outcome measures

  • The cumulative urine output measured over 3 days [Time frame: 3 days]
Secondary outcome measures (6)
  • - The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP) [Time frame: 4 days]
  • The change in serum level of Soluble suppression of tumorigenicity 2 (sST2) [Time frame: 4 days]
  • The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 ) [Time frame: 3 days]
  • The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7) [Time frame: 3 days]
  • 30-day mortality [Time frame: up to 30 days]
  • Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy [Time frame: 3 days]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta university — Tanta

Identifiers

NCT: NCT07372040 · Acute Heart Failure 2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗