Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
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 select if to be treated at their home or in the outpatient clinic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient considered to be in the acute worsening of heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload.
Patient has any known or visible lower body (non-facial) skin problems (open wounds, ulcers, infections)
Patient with severe peripheral arterial disease
Patient is pregnant or planning to become pregnant within the study period, or a lactating woman.
Trial design
Design model
Crossover
Treatments tested in this trial
AquaPass System
Devicea 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: AquaPassExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
AquaPass Performance Evaluation
Average Net Fluid Loss calculated as the difference in weight between pre- and post-AquaPass treatment sessions, in comparison to the Control Day observation. Total Average Net Fluid Loss during the Treatment Phase should be ≥ 500gr. as compared to the Total Average Net Fluid Loss during the Control Phase.
Time frame
5 daysSecondary outcomes
1
AquaPass Safety Evaluation
Incidence of device-related side effects - defined as events during or up to 1-Hour after device use
Time frame
6 hoursSponsors and contacts
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Source ClinicalTrials.gov