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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 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.

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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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2024-09-05
Est. Completion 2025-01-29
Phase NA

Sponsor

AquaPass Medical

1 total trials

What the Registry Record Tells You About NCT06360380

The ClinicalTrials.gov registry entry for NCT06360380 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 419-participant average among 12 other Chronic Heart Failure trials with a reported enrollment target (90% lower). The listed sponsor is AquaPass Medical, which has 1 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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