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NCT04481919RECRUITINGIRB Ready

Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)

(ESCALATE)

Sponsored by Vanderbilt University Medical Center

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 474 participants interested
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Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.

Who Can Participate

Inclusion Criteria

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 \> 100.5ΒΊF
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 sev

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

474 participants

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Gender

ALL

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Sponsor

Vanderbilt University Medical Center

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Nashville

Tennessee

Location available
View Nashville location page
Unknown

Nashville

Tennessee

Location available
View Nashville location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

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Looking for Heart Failure Treatment in Nashville?

Join others in Tennessee exploring innovative treatment options through clinical research

Heart Failure Treatment Options in Nashville, Tennessee

If you're searching for Heart Failure treatment in Nashville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Nashville, Nashville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Heart Failure. All study-related care is provided at no cost to participants.

Local Sites
2 locations in Tennessee
Now Enrolling
Up to 474 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Heart Failure?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Heart Failure

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Heart Failure Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04481919. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.