RecruitingNot ApplicableNCT06360380

Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System

REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients


Sponsor

AquaPass Medical Ltd.

Enrollment

40 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure. Patients will wear a lightweight suit that helps remove excess fluids through their sweat. The investigators want to see if the AquaPass system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics. Participants will select if to be treated at their home or in the outpatient clinic.


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a non-invasive device that removes excess fluid from the body — without using the kidneys — in heart failure patients who are retaining fluid (congestion) despite taking diuretic medications (water pills). Fluid overload is a common and dangerous problem in heart failure. **You may be eligible if...** - You are 21–79 years old - You have decompensated heart failure and/or chronic kidney disease (Stage 2 or higher) with significant fluid retention - You are not responding adequately to diuretics (at least 40 mg furosemide daily) - You have not been hospitalized for heart failure in the last 30 days - Your diuretic dose has not changed in the past 7 days - Your blood pressure is at least 100 mmHg systolic - Your NT-proBNP (a heart stress marker) is 600 pg/mL or above **You may NOT be eligible if...** - You have had a recent heart failure hospitalization in the past 30 days - Your blood pressure is too low - You are on dialysis or have end-stage kidney disease - You have had recent cardiac surgery or intervention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAquaPass System

a treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis


Locations(4)

Rochester Regional Health

Rochester, New York, United States

Cone Health Advanced Heart Failure Clinic at Moses Cone

Greensboro, North Carolina, United States

Rambam Medical Campus

Haifa, Israel

Rabin Medical Center

Petah Tikva, Israel

View Full Details on ClinicalTrials.gov

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NCT06360380


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