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

Part of paid clinical trials in Lakeland, Florida.

Sponsor
Lakeland Regional Health Systems, Inc.
Study ID
NCT07263035
Phase
PHASE4
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Traditional diuretic dosing adjustment per provider
  • Experimental: 50 mmol/L urine sodium
    Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L
  • Experimental: 85 mmol/L urine sodium
    Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L

Primary Outcome Measure

Natriuresis at 24 hours [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lakeland Regional HospitalLakelandFlorida33805
Andrew Bugajski, PhD, RN
863-687-1100

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