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Heart failure fluid removal device trial halted early

NCT ID NCT05318105

Disease control Sponsor: Nuwellis, 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 compared a device called Aquadex, which filters excess fluid from the blood, to standard IV diuretics in 167 hospitalized heart failure patients with fluid overload. The goal was to see which method better prevented heart failure events like rehospitalization. However, the trial was terminated early, so the results are incomplete and should be interpreted with caution.

What this could mean

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

Active substance
Aquadex Smartflow System (a device that removes excess fluid from the blood) and IV loop diuretics (medication to increase urine output)
What this could lead to
If successful, this could provide a more effective way to remove excess fluid in heart failure patients, potentially reducing hospital readmissions.
What could go wrong
The trial was terminated early, meaning it did not complete as planned. This limits the reliability of any findings, and the device may not prove better than standard diuretics.

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

167 people

The number who actually took part.

Started

Jun 2022

Finished

Apr 2026

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: * 18 years or older * Man, or non-pregnant woman * Admitted to the hospital with a diagnosis of acute decompensated heart failure * On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission * Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.) * Provide written informed consent Exclusion Criteria: * New diagnosis of heart failure * Acute coronary syndromes * Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment * Contraindications to systemic anticoagulation * Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days * Sepsis or ongoing systemic infection * Active myocarditis * Constrictive pericarditis or restrictive cardiomyopathy * Severe aortic stenosis * Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival

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Conditions

The condition(s) this trial relates to.

congestive heart failure Edema heart failure

As listed by the trial registrant

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

Fluid overload Heart failure Heart failure (for example, fluid overload)

Contacts and locations

Locations

  • Abington Jefferson Health

    Abington, Pennsylvania, 19001, United States

  • Banner Health

    Tucson, Arizona, 85721, United States

  • BayCare Medical Group, Morton Plant

    Clearwater, Florida, 33756, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75207, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Jackson Madison County General Hospital

    Jackson, Tennessee, 38301, United States

  • MemorialCare, Long Beach Medical Center

    Long Beach, California, 90806, United States

  • Mount Sinai Morningside

    New York, New York, 10025, United States

  • Northwell Health

    New York, New York, 10075, United States

  • Sentara Norfolk General Heart Hospital

    Norfolk, Virginia, 23507, United States

  • Sharp Memorial Hospital, San Diego Cardiac Center

    San Diego, California, 92123, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Mount Sinai Hospital

    New York, New York, 10029, United States

  • The Ohio State University

    Columbus, Ohio, 43215, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

More trials for these conditions

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