Efficacy of Oral Acetazolamide as Add-on Diuretic Therapy in Decongestion in Patients with Heart Failure: A Study Protocol for a Randomized Controlled Trial

Abstract

Background: Acute heart failure is a common clinical syndrome leading to hospital admission, with few evidence-based therapies for managing congestion. This trial aims to assess the efficacy of acetazolamide combined with loop diuretics in achieving decongestion among patients who fail to respond to oral diuretics and progress to acute decompensated heart failure in the absence of injectable furosemide.

Methods: This single-center, double-blind randomized controlled trial with a 1:1 allocation ratio aims to evaluate 130 patients admitted to the infusion ward. Participants will receive standard furosemide treatment and be randomized to either oral acetazolamide (250 mg twice daily) or placebo for 3 consecutive days. The primary objective is to assess the efficacy of combined oral acetazolamide and furosemide therapy in achieving decongestion. The prespecified secondary outcomes include the following: N-terminal pro-B-type natriuretic peptide levels on day 30, readmission rates within 3 months, health-related quality of life as assessed by the Heart Failure Quality of Life Questionnaire at 3 months, and changes in weight, creatinine levels, urinary sodium excretion, potassium levels, and hematological indices from the complete blood count on day 3 of the trial.

Conclusion: Diuretic resistance commonly occurs in patients with heart failure, underscoring the urgent need for innovative interventions that can effectively address the limitations of current diuretics, including diuretic resistance and electrolyte imbalances, while enhancing their efficacy in this patient population.