Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System (NCT06360380) | Clinical Trial Compass
RecruitingNot Applicable
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
United States, Israel40 participantsStarted 2024-08-12
Plain-language 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.
Who can participate
Age range
21 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. 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.)