NCT07263035

Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Lakeland Regional Health Systems, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if increasing the dose of diuretics to achieve a higher urine sodium target produces better clinical results when treating patients hospitalized with acute heart failure when compared to lower urine sodium target and standard of care. The main questions it aims to answer are: 1. Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis? 2. Does targeting a higher urine sodium goal reduce frequency of hospital readmissions? 3. Does targeting a higher urine sodium goal reduce hospital length of stay? Researchers will compare natriuresis-guided arms with standard of care to see if targeting higher natriuresis goals improves significantly over current practice. Participants will submit urine samples at routine intervals after being given diuretics to evaluate urine sodium concentration. If urine sodium is low then diuretic dose will be increased.

Detailed description

Patients will be randomized into one of three groups: 50 micromolar natriuresis, 85 micromolar natriuresis, and standard of care. The natriuresis arms will have urine sodium assessed two to four hours administration of intravenous diuretics. If the natriuretic response is inadequate they will immediately receive a higher dose of diuretic. This process will be repeated for the first 72 hours of admission.

Conditions

• Heart Failure
• Heart Failure - NYHA II - IV
• Heart Failure Acute
• Acute Heart Failure (AHF)

Interventions

Type	Name	Description
DRUG	Furosemide intravenous solution	Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L
DRUG	Furosemide intravenous solution	Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L
DRUG	Furosemide intravenous solution	Standard of care

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2025-12-04
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study