Heart FailurePhase 4US-DASHNCT07263035
Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure
A Phase 4 study testing Furosemide intravenous solution in people with Heart Failure and Heart Failure - NYHA II - IV, run by Lakeland Regional Health Systems, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure - NYHA II - IV, Heart Failure Acute
- What is being tested?
- Furosemide intravenous solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Sep 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lakeland Regional Hospital
Lakeland, Florida, 33805
Andrew Bugajski, PhD, RN, 863-687-1100, andrew.bugajski@mylrh.org
About this study
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:
Read more
- Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis?
- Does targeting a higher urine sodium goal reduce frequency of hospital readmissions?
- 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.
Read the 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)
- Being tested
- Furosemide intravenous solution
- Keywords
- Urine sodium, Diuretics, Lasix, heart failure, Acute CHF, acute HFrEF, Acute HFpEF, Natriuresis
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide intravenous solutionDrug
Also called Lasix
Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L
Furosemide intravenous solutionDrug
Also called Lasix
Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L
Furosemide intravenous solutionDrug
Also called Lasix
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Traditional diuretic dosing adjustment per provider Receives: Drug: Furosemide intravenous solution |
| 50 mmol/L urine sodium | Experimental | Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L Receives: Drug: Furosemide intravenous solution |
| 85 mmol/L urine sodium | Experimental | Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L Receives: Drug: Furosemide intravenous solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natriuresis at 24 hours
24-hour natriuresis as measured by urine sodium in a 24-hour urine collection
Measured: 24 hours
Secondary outcomes (10)
Natriuresis at 48 hours
Total urine sodium assessed by 24-hour urine collection
Measured: 48 hours after enrollment in trial
Diuresis at 24 hours
Total urine volume assessed by 24 hour collection
Measured: 24 hours after enrollment
Diuresis at 48 hours
Total urine volume assessed via 24-hour collection
Measured: 48 hours after enrollment
Length of Stay
Duration of hospitalization
Measured: 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
Proportion of participants who experience an unplanned hospital readmission for any cause within 30 days after the index hospital discharge.
Measured: 30 days after discharge
Readmission rate of any cause at 90 days
Proportion of participants who experience an unplanned hospital readmission for any cause within 90 days after the index hospital discharge.
Measured: 90 days after the time of discharge
Readmission rate of Heart failure
Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 30 days after the index hospital discharge.
Measured: 30 days
Readmission rate for heart failure
Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 90 days after the index hospital discharge.
Measured: 90 days
Weight change
Difference in weight from admission compared to discharge
Measured: Weight assessed at baseline within 24 hours of hospital admission and at discharge, with the discharge weight measured on the discharge day up to 30 days after admission.
Net fluid balance
Cumulative difference between total fluid intake and output during the hospitalization
Measured: Net fluid balance assessed from baseline Day 1 of admission through hospital discharge, with discharge assessment on the discharge day up to 30 days after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Apr 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakeland Regional Health Systems, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Bizanti, MD, Lakeland Regional Health Systems, Inc.
- Investigators
- Andrew Lurie, DO, Study director, Lakeland Regional HospitalAnas Bizanti, MD, Principal investigator, Lakeland Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263035
- Sponsor's protocol ID
- 2025_001
- Acronym
- US-DASH
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes