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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Failure Acute; Acute Heart Failure (AHF); Heart Failure - NYHA II - IV
• Intervention / Treatment: Drug: Furosemide intravenous solution; Drug: Furosemide intravenous solution; Drug: Furosemide intravenous solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Andrew Lurie, DO; Phone Number: 1443 8636871100; Email: Andrew.Lurie@myLRH.org
• Study Contact Backup: Name: Anas Bizanti, MD; Phone Number: 1443 8636871100; Email: anas.bizanti@mylrh.org

Study Locations

• United States
  • Florida
    • Lakeland, Florida, United States, 33805
      • Recruiting
      • Lakeland Regional Hospital
      • Contact: Andrew Bugajski, PhD, RN; Phone Number: 863-687-1100; Email: andrew.bugajski@mylrh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Traditional diuretic dosing adjustment per provider	Drug: Furosemide intravenous solution; Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L; Other Names: Lasix; Drug: Furosemide intravenous solution; Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L; Other Names: Lasix; Drug: Furosemide intravenous solution; Standard of care; Other Names: Lasix
Experimental: 50 mmol/L urine sodium; 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 50 mmol/L; Other Names: Lasix; Drug: Furosemide intravenous solution; Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L; Other Names: Lasix; Drug: Furosemide intravenous solution; Standard of care; Other Names: Lasix
Experimental: 85 mmol/L urine sodium; Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L	Drug: Furosemide intravenous solution; Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L; Other Names: Lasix; Drug: Furosemide intravenous solution; Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L; Other Names: Lasix; Drug: Furosemide intravenous solution; Standard of care; Other Names: Lasix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natriuresis at 24 hours	24-hour natriuresis as measured by urine sodium in a 24-hour urine collection	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natriuresis at 48 hours	Total urine sodium assessed by 24-hour urine collection	48 hours after enrollment in trial
Diuresis at 24 hours	Total urine volume assessed by 24 hour collection	24 hours after enrollment
Diuresis at 48 hours	Total urine volume assessed via 24-hour collection	48 hours after enrollment
Length of Stay	Duration of hospitalization	From the date and time of admission order until the date and time of discharge order, assessed for each participant up to 30 days after admission or death from any cause, whichever comes first.
Readmission of any cause at 30 days	Proportion of participants who experience an unplanned hospital readmission for any cause within 30 days after the index hospital discharge.	30 days after discharge
Readmission rate of any cause at 90 days	Proportion of participants who experience an unplanned hospital readmission for any cause within 90 days after the index hospital discharge.	90 days after the time of discharge
Readmission rate of Heart failure	Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 30 days after the index hospital discharge.	30 days
Readmission rate for heart failure	Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 90 days after the index hospital discharge.	90 days
Weight change	Difference in weight from admission compared to discharge	Weight assessed at baseline within 24 hours of hospital admission and at discharge, with the discharge weight measured on the discharge day up to 30 days after admission.
Net fluid balance	Cumulative difference between total fluid intake and output during the hospitalization	Net fluid balance assessed from baseline Day 1 of admission through hospital discharge, with discharge assessment on the discharge day up to 30 days after admission.

Collaborators and Investigators

• Sponsor: Lakeland Regional Health Systems, Inc.
• Investigators: Study Director: Andrew Lurie, DO, Lakeland Regional Hospital; Principal Investigator: Anas Bizanti, MD, Lakeland Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: heart failure; Diuretics; Natriuresis; Lasix; Acute CHF; Urine sodium; acute HFrEF; Acute HFpEF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Sulfur Compounds; Organic Chemicals; Amides; Aniline Compounds; Amines; Sulfonamides; Sulfanilamides; Sulfones; Furosemide
• Other Study ID Numbers: 2025_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No