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

RecruitingNAAges 21 Years - 79 YearsAllAquaPass Medical Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • AquaPass System
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Where

10 sites
UC San Diego Health-Sulpizio Cardiovascular Center
La Jolla, United States
UC San Francisco
San Francisco, United States
University of Minnesota
Minneapolis, United States
Northwell Health- Lenox Hill Hospital
New York, United States
Rochester Regional Health
Rochester, United States
Mission Hospital
Asheville, United States
Cone Health Advanced Heart Failure Clinic at Moses Cone
Greensboro, United States
Austin Heart Hospital
Austin, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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