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NCT Number: NCT07263035

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lakeland Regional Hospital

Lakeland, Florida, 33805, United States

Location status: Recruiting

Location contact

Andrew Bugajski, PhD, RN

CONTACT

[email protected]

863-687-1100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide intravenous solution

Drug

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

Other names: Lasix

Primary outcomes

  1. Natriuresis at 24 hours

    Time frame: 24 hours

    24-hour natriuresis as measured by urine sodium in a 24-hour urine collection

Secondary outcomes

  1. Natriuresis at 48 hours

    Time frame: 48 hours after enrollment in trial

    Total urine sodium assessed by 24-hour urine collection

  2. Diuresis at 24 hours

    Time frame: 24 hours after enrollment

    Total urine volume assessed by 24 hour collection

  3. Diuresis at 48 hours

    Time frame: 48 hours after enrollment

    Total urine volume assessed via 24-hour collection

  4. Length of Stay

    Time frame: 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.

    Duration of hospitalization

  5. Readmission of any cause at 30 days

    Time frame: 30 days after discharge

    Proportion of participants who experience an unplanned hospital readmission for any cause within 30 days after the index hospital discharge.

  6. Readmission rate of any cause at 90 days

    Time frame: 90 days after the time of discharge

    Proportion of participants who experience an unplanned hospital readmission for any cause within 90 days after the index hospital discharge.

  7. Readmission rate of Heart failure

    Time frame: 30 days

    Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 30 days after the index hospital discharge.

  8. Readmission rate for heart failure

    Time frame: 90 days

    Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 90 days after the index hospital discharge.

  9. Weight change

    Time frame: 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.

    Difference in weight from admission compared to discharge

  10. Net fluid balance

    Time frame: 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.

    Cumulative difference between total fluid intake and output during the hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Anas Bizanti, MD

CONTACT

[email protected]

8636871100 ext. 1443

Andrew Lurie, DO

CONTACT

[email protected]

8636871100 ext. 1443

Sponsors and collaborators

Lead sponsor

Lakeland Regional Health Systems, Inc.

Other

Registry information

Acronym: US-DASH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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