REFORM-HF Study: AquaPass System for Fluid Overload in Heart Failure
The REFORM-HF study is testing a new device called the AquaPass System for people with chronic heart failure and moderate kidney disease (CKD Stage 3) who have too much fluid in their body (fluid overload) and aren't responding well to their usual medications. The AquaPass System involves wearing a lightweight suit that helps remove extra fluid through sweat. Researchers want to see if using AquaPass can remove an additional 500mL of fluid during a treatment session, alongside your regular diuretics. The study will enroll about 40 participants aged 21 to 79. Success will be measured by how much fluid the system removes over 5 days.
- Study design
- This is an interventional study with an estimated 40 participants. It is designed to evaluate the safety and effectiveness of the AquaPass System.
- What's involved
- You would have a treatment session of up to 5 hours with the AquaPass system, either in the hospital or an outpatient clinic. You will also have blood and urine tests every morning.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for evaluating the AquaPass system's performance is measured at 5 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
At a glance
Conditions
Where it's being run
10 sites across 6 statesStudy leadership
- Scott C Feitell, DO · PRINCIPAL_INVESTIGATOR · Rochester Regional Health
Who to contact
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What this trial measures
- AQUAPASS Performance Evaluation5 days
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.