Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 signs of volume overload requiring intravenous loop diuretics. It will also assess the safety of these drugs when added to standard care. The main questions it aims to answer are: * Does acetazolamide or dapagliflozin lead to a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels? * Which drug results in better loop diuretic efficiency, as measured by weight loss per 40 mg of intravenous furosemide or equivalent? We will compare acetazolamide to dapagliflozin, both added to standard intravenous loop diuretic therapy, to see which is more effective in decongesting patients with ADHF. Participants will: * Take either acetazolamide or dapagliflozin orally every day for 3 days * Receive intravenous loop diuretics as part of standard care * Undergo regular assessments of heart failure symptoms, weight, and laboratory tests * Be followed up until hospital discharge and for 30 days after starting the study

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Critical Care Medicine Department - Cairo University Hospitals.
RECRUITING
Cairo
Contact Information
Primary
Nouran Mo Anwar, Bachelor
Nouran.Anwar@pharm.helwan.edu.eg
01124119559
Backup
Mahmoud I Mostafa, PhD
Mahmoud.ibrahim@pharma.helwan.edu.eg
01006605563
Time Frame
Start Date: 2024-08-24
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 60
Treatments
Active_comparator: Acetazolamide + Standard Care
Participants in this arm will receive:~1. Acetazolamide: 500 mg orally, once daily for 3 days~2. Intravenous loop diuretics: Administered at double the oral maintenance dose, given as follows:~ * Initial dose: Single bolus immediately after randomization~ * Subsequent doses: Split into two or more doses (separated by ≥6 hours) on each of the next 2 days The specific loop diuretic used (e.g., furosemide) will be determined by the treating physician based on the patient's prior medication regimen and clinical status.
Active_comparator: Dapagliflozin + Standard Care
Participants in this arm will receive:~1. Dapagliflozin: 10 mg orally, once daily for 3 days~2. Intravenous loop diuretics: Administered as described in Arm 1
Related Therapeutic Areas
Sponsors
Leads: Helwan University

This content was sourced from clinicaltrials.gov