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Recruiting Not applicable

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

NCT06360380 · tracked via the Priya Life Science USA tracker
Sponsor
AquaPass Medical Ltd
Phase
Not applicable
Started
2024-08-12
Last updated
2026-11-02

Condition(s) studied

Chronic Heart FailureCKD Stage 3

Investigational drug(s) / intervention(s)

AquaPass System

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

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 be treated in the hospital or in the outpatient clinic.

Eligibility

Sex
ALL
Min age
21 Years
Max age
79 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • AQUAPASS Performance Evaluation — 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.

Trial sites (10)

FacilityCityRegionStatus
UC San Diego Health-Sulpizio Cardiovascular Center La Jolla California Recruiting
UC San Francisco San Francisco California Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Northwell Health- Lenox Hill Hospital New York New York Recruiting
Rochester Regional Health Rochester New York Recruiting
Mission Hospital Asheville North Carolina Recruiting
Cone Health Advanced Heart Failure Clinic at Moses Cone Greensboro North Carolina Recruiting
Austin Heart Hospital Austin Texas Recruiting
Rambam Medical Campus Haifa Israel Recruiting
Rabin Medical Center Petah Tikva Israel Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06360380 on ClinicalTrials.gov ↗ ← All trials in the USA