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Urine-Guided diuretic dosing could revolutionize ER heart failure care

NCT ID NCT04481919

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests whether using urine sodium levels to guide diuretic dosing improves outcomes for emergency department patients with acute heart failure. About 474 adults with fluid overload will be randomly assigned to either the urine-guided protocol or standard care. The goal is to see if this personalized approach leads to better clinical status and less congestion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
diuretic therapy (furosemide or similar) guided by urine sodium levels
What this could lead to
If successful, this could provide a more effective way to manage fluid overload in acute heart failure, reducing hospital stays and improving recovery.
What could go wrong
This is a Phase 2 trial with 474 participants, so results are preliminary. The protocol may not outperform standard care, and diuretics carry risks like kidney strain or electrolyte imbalances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 474 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \> 18 * Emergency Department diagnosis of Acute Heart Failure (AHF) * Any one of the following: i. Chest radiograph or lung ultrasound consistent with AHF ii. Jugular venous distension iii. Pulmonary rales on auscultation iv. Lower extremity edema v. S3 gallop * \> 10 pounds of volume overload physician estimate or historical dry weight * IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay Exclusion Criteria: * End Stage Renal Disease (ESRD) requiring dialysis * Need for immediate intubation * Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new ST-Segment elevation/depression * Temperature \> 100.5ºF * End Stage Heart Failure: transplant list or ventricular assist device * Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin * Systolic Blood Pressure \< 90 mmHg at time of consent * LV outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy * Greater than 2 doses of IV diuretic administered at the time of screening from the time of the hospital presentation leading to this admission (outside hospital time is included) * Severe, uncorrected serum electrolyte abnormalities at the time of consent (serum potassium \<3.0 mEq/L, magnesium \<1.0 mEq/L or sodium \<125 or \>150 mEq/l) * Lack of informed consent

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Conditions

The condition(s) this trial relates to.

Emergencies heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute heart failure Heart failure

Contacts and locations

Locations

  • VA Tennessee Valley Health Service

    Nashville, Tennessee, 37232, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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