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
AquaPass Medical Ltd.
40 participants
Sep 5, 2024
INTERVENTIONAL
Conditions
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 select if to be treated at their home or in the outpatient clinic.
Eligibility
Inclusion Criteria8
- 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 Criteria17
- 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)
Interventions
a treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06360380