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

July 2, 2026 updated by: AquaPass Medical Ltd.

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

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 be treated in the hospital or in the outpatient clinic.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 excess fluids.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Haifa, Israel, 3109601
      • Petah Tikva, Israel, 49100
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Health-Sulpizio Cardiovascular Center
        • Contact:
        • Principal Investigator:
          • Ori Ben-Yehuda, MD
        • Sub-Investigator:
          • Nicholas Wettersten, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • UC San Francisco
        • Principal Investigator:
          • Liviu Klein, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Tamas Alexy, MD
        • Contact:
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Northwell Health- Lenox Hill Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sirish Vullaganti,, MD
        • Principal Investigator:
          • Gerin Stevens,, MD
        • Sub-Investigator:
          • Miguel Alvarez,, MD
      • Rochester, New York, United States, 14621
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • Mission Hospital
        • Principal Investigator:
          • Vinay Thohan, MD
        • Contact:
        • Sub-Investigator:
          • Matthew Riesbeck, MD
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Cone Health Advanced Heart Failure Clinic at Moses Cone
        • Contact:
        • Principal Investigator:
          • Benjamin Stoner, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Heart Hospital
        • Principal Investigator:
          • Kunjan Bhatt, MD
        • Contact:
        • Sub-Investigator:
          • Jerome Thomas, MD
        • Sub-Investigator:
          • Laura Calais, APRN
        • Sub-Investigator:
          • Jennifer Lord, MSN
        • Sub-Investigator:
          • Brooke Eden, APRN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic .
  3. No change in diuretic dosage in the past 5 days
  4. Subjects with eGFR between 15-89 mL/min/1.73m2
  5. Baseline NT-proBNP ≥600 pg/mL
  6. Baseline systolic blood pressure ≥100 mmHg
  7. Subject is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
  8. Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study

Exclusion Criteria:

  1. Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .
  2. Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure
  3. Known allergy to Polyester or Thermoplastic polyurethane (TPU)
  4. Subject with severe peripheral arterial disease
  5. Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.
  6. Subject with known hypothalamic disorders
  7. Subject with known hypohidrosis disorders
  8. Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.)
  9. Subject with cystic fibrosis
  10. Subject with active infections
  11. Inability or unwillingness to comply with the study requirements
  12. Subjects with unstable electrolytes or acid-base balance (as per investigator's discretion)
  13. Known Severe aortic valve or mitral valve stenosis
  14. History of a heart transplant or actively listed for a heart transplant
  15. Implanted left ventricular assist device (LVAD) or implant anticipated in <3 months
  16. Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AquaPass
An AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff
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
No Intervention: Control
An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, and body weight. These data will serve as a control for the efficacy primary endpoint comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AQUAPASS Performance Evaluation
Time Frame: 5 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.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AQUAPASS Safety Evaluation
Time Frame: 6 hours

Incidence of device- and procedure-related side effects - defined as ANY of the following events during or immediately after device use:

  • loss of consciousness
  • acute confusion/disorientation
  • cardiac arrest
  • respiratory failure or seizure
  • decrease in systolic blood pressure ≥ 20 mmHg OR mean BP ≥ 10 mmHg WITH associated symptoms (cramping, headache, lightheadedness, vomiting, or chest pain) AND need for intervention (administration of fluids)
  • skin infections
  • skin burns
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AquaPass Medical Ltd.

Investigators

  • Principal Investigator: Scott C Feitell, DO, Rochester Regional Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AQP-CLP-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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