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NCT06360380 · ClinicalTrials.gov registry record · NA
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
A NA study of Chronic Heart Failure and CKD Stage 3, sponsored by AquaPass Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT06360380: Recruiting NA study of Chronic Heart Failure and CKD Stage 3, sponsored by AquaPass Medical.
NCT06360380 is a NA study of Chronic Heart Failure and CKD Stage 3 that is actively recruiting participants, run by AquaPass Medical. The registered enrollment target is 40 participants, below the 419-participant average among 12 other Chronic Heart Failure trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06360380, a NA study of Chronic Heart Failure and CKD Stage 3, is actively recruiting participants, sponsored by AquaPass Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE AquaPass System
Study Locations (4)
Other
- Rambam Medical Campus - Haifa
- Rabin Medical Center - Petah Tikva
New York
- Rochester Regional Health - Rochester
North Carolina
- Cone Health Advanced Heart Failure Clinic at Moses Cone - Greensboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-09-05 |
| Est. Completion | 2025-01-29 |
| Phase | NA |
What NCT06360380 shows while recruiting
NCT06360380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 419-participant average among 12 other Chronic Heart Failure trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Chronic Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which AquaPass System is the first listed.
NCT06360380 reports a single indexed study location in Other, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06360380 about?
NCT06360380 is a clinical study titled "Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System". 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...
What is the current status of trial NCT06360380?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-09-05. Estimated completion is 2025-01-29.
What conditions does trial NCT06360380 study?
This clinical trial studies the following conditions: Chronic Heart Failure, CKD Stage 3.
What interventions are being tested in trial NCT06360380?
The interventions under investigation include: AquaPass System (DEVICE).
Who is sponsoring clinical trial NCT06360380?
This trial is sponsored by AquaPass Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06360380 being conducted?
This trial has 4 study locations across New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06360380's enrollment target sits among peer trials
40 12th of 12 higher than 1 of 12 other Chronic Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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