Comparison of Continuous Intravenous Infusion versus Intermittent Bolus Administration of Furosemide for Diuretic Efficiency in Patients with Acute Heart Failure

The primary objective is to evaluate the difference in diuretic effect between continuous infusion of furosemide, preceded by a loading dose, and bolus injections administered three times daily in patients hospitalized with acute heart failure with volume overload. This comparison aims to determine the most effective administration strategy for improving diuretic efficiency. The trial scopes include efficacy and therapy.

The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, including both males and females, within the specified age ranges. The cohort is composed of individuals with a clinical diagnosis of acute heart failure characterized by volume overload. Inclusion requires the presence of at least one sign of fluid excess and the anticipation of intravenous furosemide administration for a duration of at least three days.

This Phase 3 clinical trial is designed to compare the diuretic efficacy of two different administration strategies for furosemide in patients diagnosed with acute heart failure with volume overload. The study involves a comparison between continuous infusion, preceded by a loading dose, and intermittent bolus injections administered three times daily via intravenous routes. Eligible participants must be aged 18 years or older and demonstrate at least one sign of volume overload with a requirement for intravenous diuretic therapy for at least three days. The primary endpoint is the net weight loss recorded 72 hours after randomization. Secondary endpoints include net weight loss at 48 hours, changes in dyspnea measured by a Visual Analogue Scale, length of hospital stay, and survival status at 30 days. The study protocol follows a low-intervention methodology to evaluate optimal therapeutic use within standard clinical practice.

The experimental treatment consists of a combination of amiloride hydrochloride and furosemide in the pharmaceutical form PHF00245MIG. This medication is administered via intravenous bolus injection or intravenous infusion at a dose of 1000 mg. The study evaluates the diuretic efficiency in patients with acute heart failure by comparing continuous infusion, preceded by a loading dose, against bolus injections administered three times per day.

The assessment of efficacy in patients with acute heart failure focuses on evaluating the diuretic treatment effect through specific endpoints. The primary endpoint is the net weight loss measured 3 days after randomization. Secondary endpoints include net weight loss at 2 days after randomization, the change in dyspnea measured using a Visual Analogue Scale at 3 days after randomization, days alive out-of-hospital until Day 30, and the length of stay.