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

ConditionsHeart FailureHeart Failure - NYHA II - IVHeart Failure AcuteAcute Heart Failure (AHF)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLakeland Regional Health Systems, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Have a primary diagnosis of acute decompensated heart failure, and

Bilateral lower extremity pitting edema

Jugular venous distension

Hepatojugular reflex

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Furosemide intravenous solution

    Drug

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

  • Furosemide intravenous solution

    Drug

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

  • Furosemide intravenous solution

    Drug

    Standard of care

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: 50 mmol/L urine sodiumExperimental treatment 1 intervention
Group C: 85 mmol/L urine sodiumExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Natriuresis at 24 hours

24-hour natriuresis as measured by urine sodium in a 24-hour urine collection

Time frame
24 hours

Secondary outcomes

1

Natriuresis at 48 hours

Total urine sodium assessed by 24-hour urine collection

Time frame
48 hours after enrollment in trial
2

Diuresis at 24 hours

Total urine volume assessed by 24 hour collection

Time frame
24 hours after enrollment
3

Diuresis at 48 hours

Total urine volume assessed via 24-hour collection

Time frame
48 hours after enrollment
4

Length of Stay

Duration of hospitalization

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lakeland Regional Health Systems, Inc.

Lead sponsor

Source ClinicalTrials.gov
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