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

Eligibility 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
• * 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)