Actively Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Led by AquaPass Medical Ltd. · Updated on 2024-09-19
40
Participants Needed
4
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older and less than 80 years
- Known decompensated heart failure and/or chronic kidney disease stage 2 or higher with fluid overload defined by a congestion score of 3 or more
- Not responding adequately or resistant to current medical treatment with a daily dose of 40 mg furosemide or equivalent loop diuretic
- No heart failure hospitalization in the past 30 days
- No change in diuretic regimen in the past 7 days
- Baseline NT-proBNP of 600 pg/mL or higher
- Baseline systolic blood pressure of 100 mmHg or higher
- Able and willing to give written informed consent including release of medical information and HIPAA documentation
- Not participating in any other clinical investigation that may interfere with this study
You will not qualify if you...
- Acute worsening of heart failure requiring ventilation, mechanical support, pressors, or due to arrhythmia, infection, or other conditions unrelated to fluid overload
- Known or visible lower body (non-facial) skin problems such as open wounds, ulcers, or infections
- Severe peripheral arterial disease
- Pregnant, planning to become pregnant during the study, or lactating
- Renal disease with eGFR less than 25 ml/min/1.73 m2
- Known hypothalamic or hypohidrosis disorders
- Medical technology dependency such as gastric tubes or ventilators
- Cystic fibrosis
- Active infections
- Inability or unwillingness to comply with study requirements
- Unstable electrolytes or acid-base balance
- Severe aortic or mitral valve stenosis
- History of heart transplant, active heart transplant listing, or left ventricular assist device (LVAD)
- Implanted LVAD or planned implantation within 3 months
- Active malignant disease with life expectancy under 6 months
- Unstable or acutely worsening cardiac or renal conditions as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Rochester Regional Health
Rochester, New York, United States, 14621
Actively Recruiting
2
Cone Health Advanced Heart Failure Clinic at Moses Cone
Greensboro, North Carolina, United States, 27401
Actively Recruiting
3
Rambam Medical Campus
Haifa, Israel, 3109601
Actively Recruiting
4
Rabin Medical Center
Petah Tikva, Israel, 49100
Actively Recruiting
Research Team
S
Scott C Feitell, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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