Acute Decompensated Heart Failure, Chronic Heart Failure, Edema, Fluid Overload
Conditions
Brief summary
The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients. This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.
Detailed description
The AquaPass system is non-invasive and functions independently of the renal system, targeting the direct removal of fluids directly from the interstitial compartment through the skin, by activating the eccrine sweat glands. The patient wears a component that is connected to a control unit, which induces warm air to create a controlled environment around the skin, stimulating sweat production. The sweat evaporates instantly, ensuring that the patient remains dry and comfortable. In this study, the investigators would like to further investigate the efficacy of the system, when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload, and to continue the treatment in their homes, immediately after the hospitalization, for another 30 days.
Interventions
DEVICEAquaPass
The AquaPass system works by activating the body's natural sweating mechanism to remove excess fluid from the interstitial compartment. This process is achieved by wearing a garment that creates optimal microclimate conditions around the skin. The system is controlled by a portable unit that delivers warm air to the wearable component while ensuring patient safety.
Sponsors
AquaPass Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject that was hospitalized with fluid overload and a history of chronic heart failure and CKD stages 1-4 * Subject has composite congestion score ≥3. * Baseline systolic blood pressure at rest of ≥100mmHg. * Subject is capable of meeting the following study requirements: * For patients with BMI \<30 kg/m2: baseline NT-pro BNP\>1,600 pg/ml * For patients with BMI \>30 kg/m2: baseline NT-pro BNP \>800 pg/ml * For patients with rate-controlled persistent or permanent AF: NT-pro BNP \>2,400 pg/ml. * Subject successfully completes 2-4 hours of run-in acclimation session * Minimal sweat rate in the last hour of run-in acclimatization of 130gr/hours
Exclusion criteria
* Subject is enrolled to another clinical investigation that might interfere with this study. * Baseline systolic blood pressure \<100 mm Hg * Subject considered to be in the acute worsening of the heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrythmia, infection or other medical condition unrelated to fluid overload. * Subject has any known lower body skin problems (open wounds, ulcers) * Subject with severe peripheral arterial disease * Subject is pregnant or planning to become pregnant within the study period, or lactating mothers. * End-stage renal disease (eGFR\<15 ml/min/1.73 m2) or requiring dialysis. * Inability or unwillingness to comply with the study requirements. * History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD). * Implanted left ventricular assist device or implant anticipated \<3 months. * Malignancy or other noncardiac condition limiting life expectancy to \<12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Sweat Rate Per Hour per patient | 30 days | An average sweat rate of 150 ml/hr per patient at hospital and at home |
| Incidence of device- and procedure-related side-effects | 30 days | Incidences of system and treatment-related AEs and SAEs including symptomatic changes in vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in congestion score | 30 days | to evaluate the effect of the AquaPass treatment on congestion score |
| Changes in Diuretics Dose | 30 days | Documentation of changes in diuretics administration to assess safety and potential benefits with system use. |
| Incidence of worsening renal function | 30 days | Incidence of worsening renal function, measured as an increase of Creatinine levels by \>0.5mg/dL |
| Changes in NT-ProBNP levels | 30 days | Changes in NT-ProBNP levels to demonstrate the system's safety and clinical performance |
| Change in body weight | 30 days | To evaluate the effectiveness of the AquaPass System. During the study patients will weighed before and after each treatment. The weight before the first treatment and the weight after the last treatment will be used to assess the treatment performance |
| Change of quality of life | 30 days | Assessment of the quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The minimal score is zero '0' and the highest is '100' when higher scores represent a better outcome for the patient. |
| Fluid Overload Related Hospitalizations | 30 days | Hospitalization or ED visit for decompensated heart failure |
Outcome results
None listed