Chronic Heart Failure, CKD Stage 3
Conditions
Keywords
Aquapass, Sweat Enhancement, Fluid removal, CHF
Brief 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.
Detailed description
This study is being conducted to demonstrate the safety and effectiveness of the AquaPass System in reducing fluid overload in patients with decompensated heart failure and chronic kidney disease stage 2-3 who are not responding adequately or resistant to current medical treatment. The study checks if patients' fluid loss as a result of taking diuretics medications is improved when using AQUAPASS in parallel to this treatment. The evaluation of success is done by comparing participants' weight before and after the use of the AQUAPASS system, to evaluate if the system effectively removes excess fluids. Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning. The first visit will be observation only, without using AQUAPASS. This will serve as the baseline data. The investigators will compare the data of the AQUAPASS treatments with this baseline to measure the effectiveness of the system in removing excess fluids.
Interventions
DEVICEAquaPass System
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
Sponsors
AquaPass Medical Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, multicenter, single-arm, within-subject-controlled, pivotal trial, enrolling subjects with decompensated heart failure inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥80 mg furosemide or equivalent loop diuretics.
Eligibility
Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AQUAPASS Performance Evaluation | 5 days | Average Net Fluid Loss calculated as the difference in weight between pre- and post-AQUAPASS treatment sessions, in comparison to the Control Day observation. Total Average Net Fluid Loss during the Treatment Phase should be ≥ 500gr. as compared to the Total Average Net Fluid Loss during the Control Phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AQUAPASS Safety Evaluation | 6 hours | Incidence of device- and procedure-related side effects - defined as ANY of the following events during or immediately after device use: * loss of consciousness * acute confusion/disorientation * cardiac arrest * respiratory failure or seizure * decrease in systolic blood pressure ≥ 20 mmHg OR mean BP ≥ 10 mmHg WITH associated symptoms (cramping, headache, lightheadedness, vomiting, or chest pain) AND need for intervention (administration of fluids) * skin infections * skin burns |
Countries
Israel, United States
Contacts
CONTACTScott C Feitell, DO
CONTACTJulie Mooney, RN
PRINCIPAL_INVESTIGATORScott C Feitell, DO
Rochester Regional Health
Outcome results
None listed