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New device automates fluid removal in heart failure – could it be a game changer?

NCT ID NCT05174312

Disease control Sponsor: Reprieve Cardiovascular, Inc 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a bedside device called the Reprieve Decongestion Management System in 100 hospitalized patients with acute decompensated heart failure. The device automatically adjusts the dose of a diuretic (furosemide) and saline based on the patient's real-time urine output, aiming to remove excess fluid more safely and effectively than standard care. The main goals were to see if the device increases urine sodium output and reduces complications like kidney injury or electrolyte problems.

What this could mean

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

Active substance
Reprieve Decongestion Management System (a bedside device that automatically adjusts diuretic and saline infusion based on urine output)
What this could lead to
If successful, this device could help doctors remove excess fluid more safely and efficiently in heart failure patients, potentially reducing hospital stays and complications.
What could go wrong
This is a small, early-stage trial (100 participants) comparing a device to standard care. The device may not show clear benefits, and there are risks like kidney injury 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Jul 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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: 1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign. 2. ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider. 3. Prior use of loop diuretics within 30 says prior to admission. 4. ≥ 18 years of age able to provide informed consent and comply with study procedures. Exclusion Criteria: 1. Inability to place Foley catheter or IV catheter. 2. Hemodynamic instability. 3. Dyspnea due primarily to non-cardiac causes. 4. Acute infection with evidence of systemic involvement. 5. Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy. 6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated. 7. Inability to follow instructions or comply with follow-up procedures. 8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures. 9. Severe electrolyte abnormalities. 10. Presence of active coronavirus disease 2019 (COVID-19) infection. 11. Enrollment in another interventional trial during the index hospitalization. 12. Inability to return for follow-up study visits. 13. Life expectancy less than 3 months. 14. Women who are pregnant or intend to become pregnant.

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

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

Acute decompensated heart failure

Contacts and locations

Locations

  • Ascension Texas Cardiovascular

    Austin, Texas, 78705, United States

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Baylor Scott & White

    Dallas, Texas, 75246, United States

  • Cone Health

    Greensboro, North Carolina, 27401, United States

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

  • Eastern Shore Research Institute

    Fairhope, Alabama, 36532, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • Prisma Health

    Columbia, South Carolina, 29203, United States

  • St. Louis VA

    St Louis, Missouri, 63130, United States

  • The Lindner Research Center at Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Trinity Health Ann Arbor Hospital

    Ypsilanti, Michigan, 48197, United States

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Washington University

    St Louis, Missouri, 63130, United States

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Other studies related to the condition(s) this trial covers.