NCT07263035

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. 1.Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis?
  2. 2.Does targeting a higher urine sodium goal reduce frequency of hospital readmissions?
  3. 3.Does targeting a higher urine sodium goal reduce hospital length of stay?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
14mo left

Started Apr 2026

Shorter than P25 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

November 19, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

November 19, 2025

Last Update Submit

April 6, 2026

Conditions

Heart FailureHeart Failure - NYHA II - IVHeart Failure AcuteAcute Heart Failure (AHF)

Keywords

Urine sodiumDiureticsLasixheart failureAcute CHFacute HFrEFAcute HFpEFNatriuresis

Outcome Measures

Primary Outcomes (1)

  • Natriuresis at 24 hours

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

    24 hours

Secondary Outcomes (10)

  • Natriuresis at 48 hours

    48 hours after enrollment in trial

  • Diuresis at 24 hours

    24 hours after enrollment

  • Diuresis at 48 hours

    48 hours after enrollment

  • Length of Stay

    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

    30 days after discharge

  • +5 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR

Traditional diuretic dosing adjustment per provider

Drug: Furosemide intravenous solution

50 mmol/L urine sodium

EXPERIMENTAL

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

Drug: Furosemide intravenous solution

85 mmol/L urine sodium

EXPERIMENTAL

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

Drug: Furosemide intravenous solution

Interventions

Furosemide intravenous solutionDRUG

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

Also known as: Lasix
50 mmol/L urine sodium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakeland Regional Hospital

Lakeland, Florida, 33805, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Andrew Lurie, DO

    Lakeland Regional Hospital

    STUDY DIRECTOR

  • Anas Bizanti, MD

    Lakeland Regional Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Lurie, DO

CONTACT

8636871100Andrew.Lurie@myLRH.org

Anas Bizanti, MD

CONTACT

8636871100anas.bizanti@mylrh.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Program Director, Internal Medicine Residency - Principal Investigator

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 4, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(1)