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

NCT ID: NCT07263035

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-09-01

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Traditional diuretic dosing adjustment per provider

Group Type: ACTIVE_COMPARATOR

Furosemide intravenous solution

Intervention Type: DRUG

Standard of care

50 mmol/L urine sodium

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

Group Type: EXPERIMENTAL

Furosemide intravenous solution

Intervention Type: DRUG

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

85 mmol/L urine sodium

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

Group Type: EXPERIMENTAL

Furosemide intravenous solution

Intervention Type: DRUG

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

Interventions

Furosemide intravenous solution

Standard of care

Intervention Type: DRUG

Furosemide intravenous solution

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

Intervention Type: DRUG

Furosemide intravenous solution

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

Intervention Type: DRUG

Other Intervention Names

Lasix; Lasix; Lasix

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lakeland Regional Health Systems, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Anas Bizanti, MD

Associate Program Director, Internal Medicine Residency - Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Lurie, DO

Role: STUDY_DIRECTOR

Lakeland Regional Hospital

Anas Bizanti, MD

Role: PRINCIPAL_INVESTIGATOR

Lakeland Regional Hospital

Locations

Lakeland Regional Hospital

Lakeland, Florida, United States

Countries

United States

Central Contacts

Andrew Lurie, DO

Role: CONTACT

Andrew.Lurie@myLRH.org

8636871100 ext. 1443

Anas Bizanti, MD

Role: CONTACT

anas.bizanti@mylrh.org

8636871100 ext. 1443

Other Identifiers

2025_001

Identifier Type: -

Identifier Source: org_study_id