Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Start Date
8/12/2024
Completion Date
4/1/2027
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.
Detailed Description
This study is being conducted to demonstrate the safety and effectiveness of the AquaPass System in reducing fluid overload in patients with decompensated heart failure and chronic kidney disease stage 2-3 who are not responding adequately or resistant to current medical treatment. The study checks if patients' fluid loss as a result of taking diuretics medications is improved when using AQUAPASS in parallel to this treatment. The evaluation of success is done by comparing participants' weight before and after the use of the AQUAPASS system, to evaluate if the system effectively removes excess fluids. Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning. The first visit will be observation only, without using AQUAPASS. This will serve as the baseline data. The investigators will compare the data of the AQUAPASS treatments with this baseline to measure the effectiveness of the system in removing excess fluids.
Eligibility Criteria
Age Range: 21 years to 79 years
Interventions
AquaPass System
Conditions
Locations
UC San Diego Health-Sulpizio Cardiovascular Center
La Jolla, California 92037
United States
UC San Francisco
San Francisco, California 94143
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Northwell Health- Lenox Hill Hospital
New York, New York 10075
United States
Rochester Regional Health
Rochester, New York 14621
United States
Mission Hospital
Asheville, North Carolina 28801
United States
Cone Health Advanced Heart Failure Clinic at Moses Cone
Greensboro, North Carolina 27401
United States
Austin Heart Hospital
Austin, Texas 78705
United States
Rambam Medical Campus
Haifa, 3109601
Israel
Rabin Medical Center
Petah Tikva, 49100
Israel