Recruiting

Diuretics

Sponsor:

Lakeland Regional Health Systems, Inc.

Code:

NCT07263035

Conditions

Heart Failure

Heart Failure - NYHA II - IV

Heart Failure Acute

Acute Heart Failure (AHF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Furosemide intravenous solution

Furosemide intravenous solution

Furosemide intravenous solution

Study Details

Brief summary:

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.

Conditions

Heart Failure

Heart Failure - NYHA II - IV

Heart Failure Acute

Acute Heart Failure (AHF)

Study ID

NCT07263035

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Furosemide intravenous solution

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

Furosemide intravenous solution

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

Furosemide intravenous solution

Standard of care

Primary outcome measure

  • Natriuresis at 24 hours [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Andrew Lurie, DO

8636871100Andrew.Lurie@myLRH.org

Anas Bizanti, MD

8636871100anas.bizanti@mylrh.org

Locations

Lakeland Regional Hospital

Recruiting

Lakeland, Florida, United States, 33805

Contacts

Andrew Bugajski, PhD, RN

863-687-1100andrew.bugajski@mylrh.org

More Information

Sponsor

Lakeland Regional Health Systems, Inc.

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

  • Urine sodium
  • Diuretics
  • Lasix
  • heart failure
  • Acute CHF
  • acute HFrEF
  • Acute HFpEF
  • Natriuresis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lakeland Regional Health Systems, Inc. on 2026-04-09.