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Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Sponsor: AquaPass Medical Ltd.
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 be treated in the hospital or in the outpatient clinic.
Official title: REFORM-HF™ Reducing Fluid Overload Using Renal Independent systeM in Heart Failure Patients
Key Details
Gender
All
Age Range
21 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-08-12
Completion Date
2027-04
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
AquaPass 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 (10)
UC San Diego Health-Sulpizio Cardiovascular Center
La Jolla, California, United States
UC San Francisco
San Francisco, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
Northwell Health- Lenox Hill Hospital
New York, New York, United States
Rochester Regional Health
Rochester, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Cone Health Advanced Heart Failure Clinic at Moses Cone
Greensboro, North Carolina, United States
Austin Heart Hospital
Austin, Texas, United States
Rambam Medical Campus
Haifa, Israel
Rabin Medical Center
Petah Tikva, Israel