CHF, Chronic Heart Failure, Edema
Conditions
Brief summary
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients. This study will examine safety, performance and usability of the AquaPass device in two phases: Phase 1: Hospitalization treatment. Phase 2: Home/outpatient clinic treatment
Detailed description
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients. This study will examine safety, performance and usability of the AquaPass device in two phases: Phase 1: Hospitalization treatment: This phase will begin when the patients are hospitalized with chronic heart failure symptoms and fluid overloaded and undergo sequential treatments. This phase will be conducted using a prospective case-control design, with measuring endpoint during hospitalization and follow-up (after discharge). Phase 2: Home treatment: Upon investigator decision at discharge, patients will use Aqua-Pass device at home or at outpatient, after discharge, aiming to refine fluid management and prevent re-admission. This phase will require a separate Informed Consent Form (ICF) and will be conducted using a prospective single-group pre-post design. * A multi-center, prospective, open label, one arm study. * Chronic heart failure patients will be enrolled into the study when admitted to the hospital with fluid overload. * During the in-hospitalization treatment phase, patients will undergo up to 5 procedures with the Aqua-Pass device between 3-8 hours. * Following discharge and upon investigator decision, patients will sign a dedicated ICF and continue the Aqua-Pass treatments at home or in the outpatient clinic for up to 60 days, at a rate of 1-4 treatments per week. * Follow up assessments, either during visit or over the phone, 7±2 days from the last procedure
Interventions
DEVICEThe AquaPass System
The system is a non-invasive, multiple use device intended for use at the hospital, at the outpatient clinic settings or at home. The system administers warm, dry air around the patients' body in order to create environmental conditions that increase the patients' sweat rate. Throughout the treatment, fluids from the interstitial compartment are removed from the body by the eccrine sweat glands.
Sponsors
AquaPass Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. Subject was hospitalized for worsening of chronic heart failure with fluid overload. 3. Recruitment with expectation for at least 2 additional days in hospital. 4. Subject has composite congestion score ≥3. 5. Baseline systolic blood pressure ≥100. 6. Subject is capable of meeting the following study requirements: * Subject is taking a standing diuretic dose of ≥40 mg/day * For patients with BMI \<30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP)\>1,600 pg/ml * For patients with BMI \>30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) \>800 pg/ml * For patients with rate-controlled persistent or permanent Atrial Fibrillation (AF): N-terminal pro b-type natriuretic peptide (NT-proBNP) \>2,400 pg/ml. 7. Subject completes 2 hours of run-in acclimatization session as follows: * Put on the wearable and see if the patient fits inside it comfortably. * Turn on console and see if the patient feels well when the skin temperatures are at least 37°C. * Blood Pressure, Heart Rate, Core Temperature and have not changed, relative to baseline, by more than 20%. * Systolic BP does not drop below 90 mmHg in 2 consecutive measurements.
Exclusion criteria
1. Subject is enrolled to another clinical investigation that might interfere with this study. 2. Baseline systolic blood pressure \<100 mm Hg 3. 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. 4. Subject has any known lower body skin problems (open wounds, ulcers) 5. Subject with severe peripheral arterial disease 6. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers. 7. End-stage renal disease (eGFR\<15 ml/min/1.73 m2) or requiring dialysis. 8. Inability or unwillingness to comply with the study requirements. 9. History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD). 10. Implanted left ventricular assist device or implant anticipated \<3 months. 11. Malignancy or other noncardiac condition limiting life expectancy to \<12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session | In-Hospital Phase [2-10 days] | The primary performance endpoint for the in-hospital phase is the amount of fluid loss from sweat per treatment procedure (\ 4h); the target rate of sweat production is \>500 ml/session in the in-hospital phase. |
| Incidences of Device and treatment-related AEs and SAEs and symptomatic changes in vital signs | up to 70 days | Symptomatic changes in vital signs including incidences of symptomatic hypotension and a decrease of more than 50% in eGFR compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Up to 60 days | To assess the effectiveness of the AquaPass System during the treatment phase patients will be assessed for their weight prior to the first treatment and after the last treatment |
| Change of diuretic therapy | Up to 60 days | Documentation of changes in diuretics administration to assess safety and potential benefits with system use. (quantified by daily equivalent dose of furosemide). |
| Rate of Hospitalizations or emergency visits for decompensated heart failure | Up to 60 days | Documentation of CHF-related hospitalizations to assess safety and potential benefits with system use |
| Change of quality of life as assessed by the KCCQ-12 | Up to 60 days | Patients will be asked to complete the KCCQ-12 Questionnaire to evaluate their QoL during the study and assess the potential effect of the treatment on their well-being |
| Changes in NT-ProBNP levels | Up to 60 days | Changes in NT-ProBNP levels to demonstrate the system's safety and performance |
| Changes in Renal function | up to 60 days | Changes in blood electrolytes that are correlated with worsening of renal function |
Countries
Israel
Outcome results
None listed