RecruitingPhase 4

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

United States600 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 4 trial studying a specific strategy for adjusting diuretics based on urine sodium levels, does my doctor think this approach to managing fluid removal during an acute heart failure episode could be relevant to my current treatment plan?
2The trial is measuring how much sodium is removed through urine at 24 hours — can my doctor explain what that actually tells us about how well the diuretic is working, and why that matters for my recovery from acute decompensated heart failure?
3Because this trial involves adjusting diuretic doses based on real-time urine sodium testing, how often would I need to be monitored, and is that level of testing something my care team could realistically manage during my hospital stay?
4My heart failure has been classified on the NYHA scale — can my doctor tell me whether the severity of my condition would fit the type of patients this trial is designed for, and whether I'd be better served by a standard diuretic approach first?
5Since the trial is still recruiting and in Phase 4, does my doctor know of any early findings or similar studies that might give us a sense of whether a urine sodium-driven strategy has shown any meaningful advantages over the usual way diuretics are managed in acute heart failure?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Natriuresis at 24 hours

Timeframe: 24 hours

Trial details

NCT IDNCT07263035

SponsorLakeland Regional Health Systems, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Andrew Lurie, DO

8636871100 Andrew.Lurie@myLRH.org

View on ClinicalTrials.gov More Heart Failure trials