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

REFORM-HF™ Reducing Fluid Overload Using Renal Independent systeM in Heart Failure Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 79 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The REFORM-HF study tests AQUAPASS, a lightweight suit that helps remove extra fluid through sweat in adults with heart failure. The goal is to remove an extra 500 mL of fluid along with usual medicines, such as water pills. Treatment takes place in a hospital or outpatient clinic.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 21 to 79.
  • Have worsening heart failure rated NYHA class II or III, with a fluid buildup score of at least 3. Fluid buildup must continue or worsen despite taking at least 80 mg of furosemide daily, or an equal dose of a similar water pill.
  • No change in water pill dose in the past 5 days.
  • Have an eGFR kidney function test result from 15 to 89.
  • Have an NT-proBNP blood test result, a marker of heart strain, of at least 600 pg/mL.
  • Have a top blood pressure number of at least 100 mmHg.
  • Be able and willing to sign consent and medical information release forms.
  • Not be in another study that could affect this study’s results or data.

Who can't join

  • Have suddenly worsening heart failure that needs machine support for breathing or blood flow, or medicines to support blood pressure or heart pumping. Also excluded: worsening caused by an abnormal heartbeat, infection, or another condition unrelated to fluid buildup.
  • Have lower-body skin wounds, sores, or infections that could prevent suit use; an allergy to polyester or TPU, a plastic material; or a disorder that causes too little sweating.
  • Have severe narrowing of arteries outside the heart, severe narrowing of the aortic or mitral heart valve, a past heart transplant, or an active place on a heart transplant list.
  • Have an implanted heart pump called an LVAD, expect one within 3 months, or depend on devices such as a feeding tube, ventilator, or long-term IV line.
  • Are pregnant, planning pregnancy during the study, or breastfeeding.
  • Have a disorder of the hypothalamus, a part of the brain; cystic fibrosis; or an active infection.
  • Have unstable blood salts or acid levels, as judged by the study doctor, or cannot or will not follow study requirements.
  • Are expected by the study doctor to live less than 6 months because of cancer or another illness not related to the heart.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (8)

CA

MN

NC

NY

TX