NCT07263035 Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure
| NCT ID | NCT07263035 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Lakeland Regional Health Systems, Inc. |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2026-04-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: * 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
Contact & Investigator
Andrew Lurie, DO
STUDY DIRECTOR
Lakeland Regional Hospital
Frequently Asked Questions
Who can join the NCT07263035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07263035 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07263035 currently recruiting?
Yes, NCT07263035 is actively recruiting participants. Contact the research team at Andrew.Lurie@myLRH.org for enrollment information.
Where is the NCT07263035 trial being conducted?
This trial is being conducted at Lakeland, United States.
Who is sponsoring the NCT07263035 clinical trial?
NCT07263035 is sponsored by Lakeland Regional Health Systems, Inc.. The principal investigator is Andrew Lurie, DO at Lakeland Regional Hospital. The trial plans to enroll 600 participants.
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