Clinical trial NCT06401109: Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry
Official title: Evaluating the Safety and Efficacy of the AquaPass System a Renal-independent Fluid Removal System in ADHF Patients Suffering From Fluid Overload. a European Registry
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Heart Failure
Fluid Overload
Acute Decompensated Heart Failure
Edema
Lead sponsor: AquaPass Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average Sweat Rate Per Hour per patient
timeFrame: 30 days
measure: Incidence of device- and procedure-related side-effects
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of worsening renal function
timeFrame: 30 days
measure: Fluid Overload Related Hospitalizations
timeFrame: 30 days
measure: Changes in congestion score
timeFrame: 30 days
measure: Changes in Diuretics Dose
timeFrame: 30 days
measure: Change of quality of life
timeFrame: 30 days
measure: Changes in NT-ProBNP levels
timeFrame: 30 days
measure: Change in body weight
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: