Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry (REFORM-HF II)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Edema; Chronic Heart Failure; Acute Decompensated Heart Failure; Fluid Overload
• Intervention / Treatment: Device: AquaPass

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: AquaPass; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Sweat Rate Per Hour per patient	An average sweat rate of 150 ml/hr per patient at hospital and at home	30 days
Incidence of device- and procedure-related side-effects	Incidences of system and treatment-related AEs and SAEs including symptomatic changes in vital signs	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of worsening renal function	Incidence of worsening renal function, measured as an increase of Creatinine levels by >0.5mg/dL	30 days
Fluid Overload Related Hospitalizations	Hospitalization or ED visit for decompensated heart failure	30 days
Changes in congestion score	to evaluate the effect of the AquaPass treatment on congestion score	30 days
Changes in Diuretics Dose	Documentation of changes in diuretics administration to assess safety and potential benefits with system use.	30 days
Change of quality of life	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.	30 days
Changes in NT-ProBNP levels	Changes in NT-ProBNP levels to demonstrate the system's safety and clinical performance	30 days
Change in body weight	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	30 days

Collaborators and Investigators

• Sponsor: AquaPass Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: AQP-CLP-044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No