Reducing fluid overload in heart failure patients with a new non-invasive system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The REFORM-HF study tests the AquaPass system, a lightweight suit designed to help patients with chronic heart failure and chronic kidney disease stage 2-3 remove excess fluids through sweating. Participants will wear the suit while continuing their regular medications, such as diuretics, to see if AquaPass can enhance fluid removal by an additional 500mL. The study will compare participants' weight before and after using the system to evaluate its effectiveness, alongside daily blood and urine tests to monitor kidney and heart function. Patients can choose to participate from home or in an outpatient clinic setting.

Why it matters

Who can join: the full rules

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

Where it's running

• UC San Diego Health-Sulpizio Cardiovascular Center
  La Jolla, California, United States Recruiting
• UC San Francisco
  San Francisco, California, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Northwell Health- Lenox Hill Hospital
  New York, New York, United States Recruiting
• Rochester Regional Health
  Rochester, New York, United States Recruiting
• Mission Hospital
  Asheville, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Scott C Feitell, DO — Rochester Regional Health
• Study coordinator: Scott C Feitell, DO
• Email: scott.feitell@rochesterregional.org
• Phone: (585) 442 5320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.