REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients
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 select if to be treated at their home or in the outpatient clinic.
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 exce…
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥21 years and \< 80 years * Patient, with known decompensated heart failure and/or CKD stage 2 or more presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 40 mg furosemide or greater or the equivalent dose of another loop diuretic. * Patients with no Heart Failure related hospitalization in the past 30 days * No change in diuretic regimen in the past 7 days * Baseline NT-proBNP ≥600 pg/mL * Baseli…
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 HealthRochester, New York
- Cone Health Advanced Heart Failure Clinic at Moses ConeGreensboro, North Carolina
- Rambam Medical CampusHaifa
- Rabin Medical CenterPetah Tikva