Status:

RECRUITING

Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients

Lead Sponsor:

Helwan University

Conditions:

Acute Decompensated Heart Failure

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The goal of this clinical trial is to compare the effectiveness of acetazolamide versus dapagliflozin as an add-on in treating acute decompensated heart failure (ADHF) in adult patients with clinical ...

Detailed Description

A. Study design * Prospective, open-label, randomized, two-armed parallel comparator study. * Participants recruited in the study must provide written informed consent after obtaining ethical approva...

Eligibility Criteria

Inclusion

  • Male or female patients of 18 years of age or older.
  • An elective or emergency hospital admission with clinical diagnosis of decompensated HF 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).
  • Assessed LVEF by any imaging technique; i.e. echocardiography, catheterization, nuclear scan magnetic resonance imaging within 12 months of inclusion.

Exclusion

  • The receipt of acetazolamide maintenance therapy.
  • Receipt of an SGLT2 inhibitor in the 48 hours before randomization.
  • An estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73 m2.
  • Use of any non-protocol defined diuretic agent with the exception of mineralocorticoid receptor antagonists during the treatment phase of the study. Thiazides, metolazone, indapamide and amiloride should be stopped upon study inclusion. If patient is taking a combination drug including a thiazide-type diuretic, the thiazide-type diuretic should be stopped.

Key Trial Info

Start Date :

August 24 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2025

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06535529

Start Date

August 24 2024

End Date

September 1 2025

Last Update

August 5 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Critical Care Medicine Department - Cairo University Hospitals.

Cairo, Egypt