Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Recruiting
N/A
Interventional Study
Chronic Heart Failure
CKD Stage 3
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 21 – 79
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- AquaPass Medical Ltd. · Industry
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥21 years and \< 80 years
2. 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…
Contacts