Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure (US-DASH)

Lakeland Regional Health Systems, Inc.

Status and phase: Not yet enrolling; Phase 4

Conditions: Heart Failure - NYHA II - IV; Acute Heart Failure (AHF); Heart Failure; Heart Failure Acute

Treatments: Drug: Furosemide intravenous solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07263035

2025_001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study will target adults 18 years of age or older admitted to Lakeland Regional Medical Center who:

  • Have a primary diagnosis of acute decompensated heart failure, and

  • Have at least one of the following signs of hypervolemia:

    • Bilateral lower extremity pitting edema
    • Jugular venous distension
    • Hepatojugular reflex
    • Crackles on pulmonary exam, or
    • Chest x-ray demonstrating pulmonary edema or pleural effusions

Exclusion criteria

• Exclusion criteria include:

  • Admission to the intensive care unit
  • Presence of ST-elevated myocardial infarction
  • Presence of type 1 non-ST elevated myocardial infarction
  • Dyspnea primarily due to non-cardiac cause as judged by the emergency medicine physician or admitting physician
  • Use of supplemental oxygen totaling at least 3 L per minute or greater at baseline
  • Anuria
  • End-stage renal disease per KDIGO criteria
  • Dialysis use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Control

Active Comparator group

Description:

Traditional diuretic dosing adjustment per provider

Treatment:

Drug: Furosemide intravenous solution

Drug: Furosemide intravenous solution

Drug: Furosemide intravenous solution

50 mmol/L urine sodium

Experimental group

Description:

Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L

Treatment:

Drug: Furosemide intravenous solution

Drug: Furosemide intravenous solution

Drug: Furosemide intravenous solution

85 mmol/L urine sodium

Experimental group

Description:

Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L

Treatment:

Drug: Furosemide intravenous solution

Drug: Furosemide intravenous solution

Drug: Furosemide intravenous solution