Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-79
SponsorAquaPass Medical Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥21 years and < 80 years
Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) 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 80 mg furosemide or greater or the equivalent dose of another loop diuretic .
No change in diuretic dosage in the past 5 days
Subjects with eGFR between 15-89 mL/min/1.73m2
Disqualifiers
Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .
Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure
Known allergy to Polyester or Thermoplastic polyurethane (TPU)
Subject with severe peripheral arterial disease
Trial design
Treatments tested in this trial
- AquaPass System
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov