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

Recruiting now · Not applicable

Conditions studied: Chronic Heart Failure, CKD Stage 3

In brief

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.

Key facts

Study ID

NCT06360380

Run by

AquaPass Medical Ltd.

People needed

40

Starts

2024-08-12

Expected to finish

2027-04-01

Last updated by the study team

2026-07-06

Who can join

Age: 21 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is pregnant or planning to become pregnant within the study period, or a lactating woman.
• Subject with known hypothalamic disorders
• Subject with known hypohidrosis disorders
• Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.)
• Subject with cystic fibrosis
• Subject with active infections
• 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
• History of a heart transplant or actively listed for a heart transplant
• Implanted left ventricular assist device (LVAD) or implant anticipated in <3 months
• Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities

Where it is running

• UC San Diego Health-Sulpizio Cardiovascular Center — La Jolla, California, United States (enrolling)
• UC San Francisco — San Francisco, California, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Northwell Health- Lenox Hill Hospital — New York, New York, United States (enrolling)
• Rochester Regional Health — Rochester, New York, United States (enrolling)
• Mission Hospital — Asheville, North Carolina, United States (enrolling)
• Cone Health Advanced Heart Failure Clinic at Moses Cone — Greensboro, North Carolina, United States (enrolling)
• Austin Heart Hospital — Austin, Texas, United States (enrolling)
• Rambam Medical Campus — Haifa, Israel (enrolling)
• Rabin Medical Center — Petah Tikva, Israel (enrolling)

Full record on ClinicalTrials.gov

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