NCT06036914

A Study of Ultra High Dose Diuretics to Treat Heart Failure

Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness of ultrahigh dose diuretics compared to standard dose diuretics over 24 hours in patients with decompensated heart failure.

Conditions

• Heart Failure; With Decompensation

Interventions

Type	Name	Description
DRUG	Bumetanide	Bumetanide will be administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
DRUG	Furosemide	Furosemide will be administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours. Furosemide equivalents will be considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study will be 40 mg IV two times a day (BID) and the maximum dose will be 100 mg IV BID.

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-10-08
• Completion: 2024-10-08
• First posted: 2023-09-14
• Last updated: 2026-01-14
• Results posted: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study