Recruiting

Fluid Overload

Sponsor:

AquaPass Medical Ltd.

Code:

NCT06360380

Conditions

Chronic Heart Failure

CKD Stage 3

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

AquaPass System

Study Details

Brief 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 be treated in the hospital or in the outpatient clinic.

Conditions

Chronic Heart Failure

CKD Stage 3

Study ID

NCT06360380

Start date

Aug 12, 2024

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AquaPass

An AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff

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.

Interventions

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

Primary outcome measure

  • AQUAPASS Performance Evaluation [ Time Frame: 5 days ]

Central Contacts and Locations

Locations

UC San Diego Health-Sulpizio Cardiovascular Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Ori Ben-Yehuda, MD

UC San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Liviu Klein, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Gretchen Peichel, RN-CRC

612-626-6237gpeichel@umn.edu

Principal Investigator:

Tamas Alexy, MD

Northwell Health- Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Principal Investigator:

Gerin Stevens,, MD

Rochester Regional Health

Recruiting

Rochester, New York, United States, 14621

Contacts

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Contacts

Principal Investigator:

Vinay Thohan, MD

Cone Health Advanced Heart Failure Clinic at Moses Cone

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Principal Investigator:

Benjamin Stoner, MD

Austin Heart Hospital

Recruiting

Austin, Texas, United States, 78705

Contacts

Principal Investigator:

Kunjan Bhatt, MD

More Information

Sponsor

AquaPass Medical Ltd.

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Aquapass
  • Sweat Enhancement
  • Fluid removal
  • CHF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AquaPass Medical Ltd. on 2026-07-06.