Reducing fluid overload in heart failure patients with a new non-invasive system
REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients
This study is testing a new suit that helps people with heart failure and kidney issues sweat out extra fluids to see if it can improve their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | AquaPass Medical Ltd. Industry-sponsored |
| Locations | 4 sites (Rochester, New York and 3 other locations) |
| Trial ID | NCT06360380 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 80 with decompensated heart failure or CKD stage 2-3 who are experiencing fluid overload and are resistant to current treatments.
Not a fit: Patients who have had a heart failure-related hospitalization in the past 30 days or have recently changed their diuretic regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve fluid management in heart failure patients, leading to better health outcomes.
How similar studies have performed: While the AquaPass system represents a novel approach, similar non-invasive fluid removal techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥21 years and \< 80 years * Patient, with known decompensated heart failure and/or CKD stage 2 or more 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 40 mg furosemide or greater or the equivalent dose of another loop diuretic. * Patients with no Heart Failure related hospitalization in the past 30 days * No change in diuretic regimen in the past 7 days * Baseline NT-proBNP ≥600 pg/mL * Baseline systolic blood pressure ≥100 mmHg * Patient 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 * Patient is not participating in any clinical investigation that may interfere with the data collection or the results of this study Exclusion Criteria: * Patient considered to be in the acute worsening of heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload. * Patient has any known or visible lower body (non-facial) skin problems (open wounds, ulcers, infections) * Patient with severe peripheral arterial disease * Patient is pregnant or planning to become pregnant within the study period, or a lactating woman. * Renal disease with eGFR \<25 ml/min/1.73 m2 * Patients with known hypothalamic disorders * Patients with known hypohidrosis disorders * Patients with medical technology dependency (gastric (G) tubes, ventilators etc.) * Patients with cystic fibrosis * Patients with active infections * Inability or unwillingness to comply with the study requirements * Patients with unstable electrolytes or acid-base balance (per investigator's discretion) * Known Severe aortic valve or mitral valve stenosis * History of a heart transplant or actively listed for a heart transplant or LVAD * Implanted left ventricular assist device or implant anticipated \<3 months * Patients with an active, malignant disease and whose life expectancy is \< 6 months (per investigator's discretion) * Unstable or acutely worsening cardiac or renal conditions (per investigator's discretion)
Where this trial is running
Rochester, New York and 3 other locations
- Rochester Regional Health — Rochester, New York, United States (Recruiting)
- Cone Health Advanced Heart Failure Clinic at Moses Cone — Greensboro, North Carolina, United States (Recruiting)
- Rambam Medical Campus — Haifa, Israel (Recruiting)
- Rabin Medical Center — Petah Tikva, Israel (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.