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

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

Recruiting
18 years and older
All
Phase 4

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Overview

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.

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.

Eligibility

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

Study details
    Heart Failure
    Heart Failure - NYHA II - IV
    Heart Failure Acute
    Acute Heart Failure (AHF)

NCT07263035

Lakeland Regional Health Systems, Inc.

13 May 2026

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