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Diuretic

Diuretic Therapy for Heart Failure (ESCALATE Trial)

Phase 2

Recruiting

Led By Sean P. Collins, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay

Emergency Department diagnosis of Acute Heart Failure (AHF)

Must not have

Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin

End Stage Heart Failure: transplant list or ventricular assist device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days from randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to give diuretics to people with heart failure in the emergency room, using less medication while still keeping sodium levels low.

Who is the study for?

The ESCALATE trial is for adults over 18 with Acute Heart Failure (AHF) diagnosed in the Emergency Department. They must have symptoms like edema, chest X-ray or ultrasound showing AHF, jugular vein swelling, lung crackles, S3 heart sound, or significant weight gain from fluid. Patients already on IV diuretics may qualify but not if they've had more than two doses before screening.

What is being tested?

This study tests a new way to use diuretics based on urine sodium levels against usual care in patients with acute heart failure. Participants are randomly assigned to either the test protocol or standard treatment after their initial emergency department evaluation.

What are the potential side effects?

Diuretic therapy can cause dehydration, electrolyte imbalances (like low potassium), kidney function changes and sometimes blood pressure drops. The specific side effects will depend on how each person's body responds to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled to receive IV diuretics during my first day in the hospital.

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I was diagnosed with Acute Heart Failure in the Emergency Department.

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I am older than 18 years.

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I have swelling in my legs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications that can harm my hearing.

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I am listed for a heart transplant or have a ventricular assist device.

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I have a severe heart valve problem or cardiomyopathy.

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I need a tube inserted to help me breathe right away.

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I have had symptoms of a heart attack with changes in my ECG.

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I am on dialysis for end-stage kidney disease.

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I've received more than 2 IV diuretic doses since being admitted to the hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Status Score

Secondary study objectives

Average daily natriuresis

CV Death and AHF Readmission

Change in natriuretic peptides

+8 more

Other study objectives

180-day all cause death

Acute Kidney Injury Differences in Epithelial sodium channel (ENaC) levels

CV death or Myocardial Infarction (MI) during hospitalization

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Protocolized spot urine sodium guided diuretic therapyActive Control1 Intervention

Patients will have a spot urine sodium and urine creatinine obtained. The urine and creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance. Performed 3 times per day, diuretic dosing will be individualized based on the proportion of 24-hour diuresis achieved since the prior IV diuretic dose. Every 24 hours new goals for urine output and net negative fluid balance are established based on the study and treatment team's assessment of residual congestion until protocol completion.

Group II: Guideline-based careActive Control1 Intervention

Patients will be placed on guideline-based diuretic dosing consistent with usual practice. The initial dose will be two times their home dose and will be subsequently adjusted by the treating team based on renal function and symptom severity. The treating team can increase or decrease the frequency and dose of diuretic based on urine output and clinical assessment. Patients in this arm also have urine collected 3 times per day by the bedside nurse to mirror the intervention arm.

0 / 11Eligibility criteria met