NCT06360380

Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System

REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AquaPass Medical Ltd. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 excess fluids. Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning. The first visit will be observation only, without using AquaPass. This will serve as the baseline data. The investigators will compare the data of the AquaPass treatments with this baseline to measure the effectiveness of the system in removing access fluids.

Conditions

• Chronic Heart Failure
• CKD Stage 3

Interventions

Type	Name	Description
DEVICE	AquaPass 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

Timeline

• Start date: 2024-09-05
• Primary completion: 2025-01-03
• Completion: 2025-01-29
• First posted: 2024-04-11
• Last updated: 2024-09-19

Locations

4 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study