Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
NCT ID: NCT06360380
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-09-05
2025-01-29
Brief Summary
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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.
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Detailed Description
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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 access fluids.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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AquaPass
An AquaPass treatment session (up to 5-Hrs.) will be administered in the outpatient settings or at home and supervised by a certified study staff
AquaPass 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
Control
An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, body weight, and quality of life. These data will serve as a control for the efficacy primary endpoint comparison.
No interventions assigned to this group
Interventions
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AquaPass 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
Eligibility Criteria
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Inclusion Criteria
* 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 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)
21 Years
80 Years
ALL
No
Sponsors
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AquaPass Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Scott C Feitell, DO
Role: PRINCIPAL_INVESTIGATOR
Rochester Regional Health
Locations
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Rochester Regional Health
Rochester, New York, United States
Cone Health Advanced Heart Failure Clinic at Moses Cone
Greensboro, North Carolina, United States
Rambam Medical Campus
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AQP-CLP-004
Identifier Type: -
Identifier Source: org_study_id
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