Testing a Device to Remove Extra Fluid in Heart Failure Patients
Tests the AquaPass device, a wearable suit, in adults with heart failure and fluid overload.
Plain-language title generated from the registry record
Registry title: Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Key facts
- Where
- Asheville, Austin, Greensboro, La Jolla, Minneapolis, New York, Rochester, and San Francisco, United StatesSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 79 years old?
Source: NCT06360380, who can take part
Where in United States
- Mission HospitalAsheville, United StatesTaking people
- Austin Heart HospitalAustin, United StatesTaking people
- Cone Health Advanced Heart Failure Clinic at Moses ConeGreensboro, United StatesTaking people
- UC San Diego Health-Sulpizio Cardiovascular CenterLa Jolla, United StatesTaking people
- University of MinnesotaMinneapolis, United StatesTaking people
- Northwell Health- Lenox Hill HospitalNew York, United StatesTaking people
- Rochester Regional HealthRochester, United StatesTaking people
- UC San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AquaPass Medical Ltd.
- Trial code
- NCT06360380
- Record updated
- 2 November 2026
- Original description
The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.Read full original descriptionShow less
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.
Inclusion: Age ≥21 years and < 80 years; 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 ; No change in diuretic dosage in the past 5 days; Subjects with eGFR between 15-89 mL/min/1.73m2; Baseline NT-proBNP ≥600 pg/mL; Baseline systolic blood pressure ≥100 mmHg; 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; Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study.
Exclusion: Implanted left ventricular assist device (LVAD) or implant anticipated in <3 months; 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 ; 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; Known allergy to Polyester or Thermoplastic polyurethane (TPU); Subject with severe peripheral arterial disease; Subject with known hypothalamic disorders; Subject with known hypohidrosis disorders; Subject with active infections; History of a heart transplant or actively listed for a heart transplant; Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities; Subject is pregnant or planning to become pregnant within the study period, or a lactating woman; Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.); Subject with cystic fibrosis; Inability or unwillingness to comply with the study requirements; Subjects with unstable electrolytes or acid-base balance (as per investigator's discretion); Known Severe aortic valve or mitral valve stenosis.