New device automates fluid removal to ease heart failure symptoms
NCT ID NCT06272734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests the Reprieve System, a bedside device that automatically adjusts the delivery of a diuretic (furosemide) and saline based on the patient's real-time urine output. The goal is to safely and quickly remove excess fluid from 50 hospitalized adults with acute decompensated heart failure. The study focuses on whether the device works as intended without causing harm.
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 (a bedside device that automatically delivers the diuretic furosemide and saline based on real-time urine output)
- What this could lead to
- If successful, this device could offer a safer, more personalized way to remove excess fluid in heart failure patients, potentially reducing hospital stays and complications.
- What could go wrong
- This is a very early pilot study with only 50 participants, so results may not apply to all patients. The device could malfunction or cause side effects like dehydration or kidney issues.
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
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 (dyspnea, orthopnea, or edema/swelling) AND 1 sign (peripheral edema, ascites, jugular venous distension, pulmonary vascular congestion on chest radiography) 2. ≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated by health care provider. 3. Patients ≥ 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 or other urologic issues that would predispose the patient to a high rate of urogenital trauma or infection with catheter placement. 2. Hemodynamic instability as defined by any of the following: systolic blood pressure \<90 mmHg, use of vasopressors, use of IV inotropes to treat hypotension (systolic blood pressure \<90 mm Hg) or suspected/confirmed low cardiac output/shock, mechanical circulatory support, uncontrolled arrhythmias, active severe bleeding, or confirmed or suspected cardiogenic shock. Note: In the absence of the above conditions, use of inotropes to augment diuresis is permitted. 3. Dyspnea due primarily to non-cardiac causes (e.g., severe chronic obstructive pulmonary disease or pneumonia). 4. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count). 5. Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy (RRT). 6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, known severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment (within previous week), 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 protocol instructions or follow-up procedures. 9. Severe baseline electrolyte abnormalities (e.g., serum potassium \<3.0 mEq/L or magnesium \<1.3 mEq/L). Note: These are based on baseline/screening labs. Subjects whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial. 10. Serum sodium \<135 mmol/L or history of severe hyponatremia 11. Poorly controlled diabetes 12. Enrollment in another interventional trial during the index hospitalization 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tbilisi Heart and Vascular Clinic
RECRUITINGTbilisi, 0159, Georgia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stick-On patch aims to catch dangerous heart decline sooner
- Blood test clues: could two proteins predict heart failure crises?
- Are heart failure patients taking their meds? a urine test at the ER aims to find out
- Can common heart drugs stay safe during a crisis? a trial investigates
- Heart failure fluid removal device trial halted early
- Massive new registry aims to unlock secrets of deadly heart shock