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New device aims to safely drain fluid in heart failure patients

NCT ID NCT06898515

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests the Reprieve System, a bedside device that automatically adjusts diuretic and saline infusion based on a patient's urine output, to treat acute decompensated heart failure. Researchers will compare it to standard diuretic therapy in 400 hospitalized adults. The goal is to see if the device removes fluid more efficiently, reduces hospital readmissions, and lowers the risk of death within 30 days.

What this could mean

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

Active substance
Reprieve System (device delivering furosemide and saline based on urine output)
What this could lead to
If successful, this could offer a safer, more effective way to remove excess fluid in heart failure patients, potentially reducing hospital readmissions and improving survival.
What could go wrong
This is a Phase 3 trial, but results may not apply to all heart failure patients. The device is complex and could cause side effects like kidney injury or infections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

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

Started

Jul 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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

22 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. Diagnosis of HF with expected hospitalization \>24 hours, with \>1 new or worsening symptom and \>2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific treatment 2. ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider. 3. Current outpatient prescription for daily loop diuretic. 4. Participants ≥ 22 years of age able to provide informed consent and comply with study procedures. 5. Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output \<1L in the 6 hours following IV loop diuretic \>=40 mg furosemide equivalent OR Spot urine sodium \<100 mmol/L 1-2 hours after IV loop diuretic \>= 40 mg furosemide equivalent Exclusion Criteria: 1. Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to place a Foley catheter. 2. Hemodynamic instability as defined by any of the following: sustained systolic blood pressure \<90 mmHg for \>15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and/or current or previous mechanical circulatory support within the last week. 3. Uncontrolled arrhythmias defined as sustained HR \>130 beats/min for \>10 minutes within the past 48 hours. 4. Severe lung disease with chronic home oxygen requirement \>2L/min. 5. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count). 6. Estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy (RRT). 7. Significant left ventricular outflow obstruction, severe uncorrected complex congenital heart disease, known severe stenotic valvular disease, severe infiltrative or constrictive cardiomyopathy or other diagnosis that would make aggressive decongestion unsafe. 8. Current or recent (\< 30 days) type I myocardial infarction (e.g., acute coronary syndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypass surgery, or stroke. An isolated troponin elevation (e.g., from volume overload or demand ischemia) is not a reason for exclusion. 9. Severe electrolyte abnormalities (e.g., serum potassium \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<125 mEq/L). Note: These are based on baseline/screening labs. Participants whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial. 10. Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and/or follow-up visits, including expected prolonged hospitalization for reasons other than decongestive therapy 11. Currently enrolled in an interventional trial (observational studies are permitted). 12. Life expectancy less than 6 months. 13. Women who are pregnant or breastfeeding.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    53 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Azienda Ospedaliera Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • ASST Niguarda Great Metropolitan Hospital

    NOT_YET_RECRUITING

    Milan, 20162, Italy

  • Advocate Christ Medical Center

    NOT_YET_RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Atrium Health Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Aurora St. Luke's Medical Center

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Baylor College of Medicine Ben Taub Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Baylor Scott and White

    RECRUITING

    Dallas, Texas, 75246, United States

  • Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46000, Spain

  • Corewell Health Butterworth Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Corewell William Beaumont University Hospital

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Duke University

    NOT_YET_RECRUITING

    Durham, North Carolina, 27710, United States

  • Hannover University Hospital

    RECRUITING

    Hanover, 30625, Germany

  • Harry S. Truman Veteran's Memorial Hospital

    NOT_YET_RECRUITING

    Columbia, Missouri, 65201, United States

  • Hospital General Valencia

    RECRUITING

    Valencia, 46000, Spain

  • Hospital Ramon y Cajal

    RECRUITING

    Madrid, 28000, Spain

  • Hospital de Bellvitge

    RECRUITING

    Barcelona, 08907, Spain

  • Inova Fairfax Medical Campus

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Jena University Hospital

    NOT_YET_RECRUITING

    Jena, 07747, Germany

  • Lindner Center at Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Medical University of Białystok

    RECRUITING

    Bialystok, 15-089, Poland

  • Medical University of Lodz

    RECRUITING

    Lodz, 70445, Poland

  • Memorial Hermann-Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Moses H. Cone Memorial Hospital

    NOT_YET_RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Northeast Georgia Medical Center

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Ohio State University Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oklahoma Heart Hospital

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Piedmont Atlanta Hospital

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Piedmont Augusta Hospital

    RECRUITING

    Augusta, Georgia, 30901, United States

  • Prisma Health Greenville Memorial Hospital

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Puerta de Hierro Majadahonda University Hospital

    RECRUITING

    Madrid, 28222, Spain

  • Scripps Memorial Hospital

    NOT_YET_RECRUITING

    La Jolla, California, 92037, United States

  • St. Louis VA

    RECRUITING

    St Louis, Missouri, 63130, United States

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Trinity Health Ann Arbor Hospital

    RECRUITING

    Ann Arbor, Michigan, 48197, United States

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UH Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • UW Harborview

    RECRUITING

    Seattle, Washington, 98104, United States

  • Universitaria delle Marche

    NOT_YET_RECRUITING

    Ancona, 60121, Italy

  • University Hospital Heidelberg

    RECRUITING

    Heidelberg, Germany

  • University Hospital Wroclaw

    RECRUITING

    Wroclaw, 45573, Poland

  • University of California Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45221, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66103, United States

  • University of Louisville Hospital

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Mississippi

    RECRUITING

    Jackson, Mississippi, 38677, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 191904, United States

  • Universitätsklinikum Gießen (UKGM)

    RECRUITING

    Giessen, 35392, Germany

  • VCU Medical Center

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, 08035, Spain

  • Washington University

    RECRUITING

    St Louis, Missouri, 63130, United States

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