Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload

Launched by JOHANNES GRAND · Dec 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best ways to treat adults with acute heart failure who have excess fluid in their bodies, a condition known as volume overload. The focus is on patients who do not respond well to standard diuretics, which are medications used to help remove extra fluid. In this trial, researchers are comparing the effectiveness of standard diuretics combined with two other medicines, Metolazone and Acetazolamide, to see if this combination works better than using diuretics alone. The goal is to find out which treatment helps patients stay out of the hospital longer and feel better overall.

To be eligible for the trial, participants must be 18 years or older, currently hospitalized due to acute heart failure with signs of fluid overload, and at risk of not responding to standard diuretic treatment. However, those with certain heart conditions, very low blood pressure, or who have had specific treatments before joining the study will not be included. Participants can expect to be closely monitored over a period of 30 days to see how well the treatment works. The trial aims to include around 1,041,939 patients over three years, and it is currently recruiting participants. By participating, individuals may contribute to finding better treatments for heart failure, potentially improving care for many others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Acute hospital admission with a clinical diagnosis of acute heart failure with volume overload.
• 3. Display risk of diuretic resistance, characterized by:
• • 1. Daily loop-diuretics administration for a minimum of 7 days before admission, or
• • 2. Insufficient decongestion observed in the preceding 24 hours (weight reduction \<500g or negative fluid balance \<1L) despite being treated with high-dose IV loop diuretic (equivalent to ≥120 mg IV furosemide within 24 hours).
• • 4. Clinical signs of congestion, indicated by one or more of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiological/ultrasonic evidence of pulmonary congestion.
• Exclusion Criteria:
• • 1. Acute coronary syndrome
• • 2. Systolic blood pressure \<85 mmHg
• • 3. Use of renal replacement therapy or ultrafiltration in-hospital before study inclusion
• • 4. Treatment with acetazolamide or metolazone during the index hospitalization prior to randomization
• • 5. Known allergy to any of the used drugs
• • 6. Severe hypokalemia (\<2.5 mmol/l) or severe hyponatremia (\<125 mmol/l)
• • 7. Severe hepatic impairment or liver cirrhosis
• • 8. Known pregnancy