Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry
- Conditions
- Chronic Heart FailureFluid OverloadAcute Decompensated Heart FailureEdema
- Interventions
- Device: AquaPass
- Registration Number
- NCT06401109
- Lead Sponsor
- AquaPass Medical Ltd.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AquaPass AquaPass Patients hospitalized with chronic heart failure symptoms and fluid overload will be treated in two phases: Phase 1: 'In Hospital' Phase: Patients will be enrolled in the study when admitted to the hospital with fluid overload. Use of the AquaPass system will be performed in the hospital, alongside diuretic therapy. Phase 2: 'At Home' Phase: Upon the investigator's decision at discharge, the patients will be enrolled in this phase of the study, and will receive AquaPass treatment sessions at their home.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
Fluid Overload Related Hospitalizations 30 days Hospitalization or ED visit for decompensated heart failure
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.
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