AquaPass Device in Treatment of CHF Patients

NCT05843201 | Completed

• 1 other identifier: AQP-009
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Heart Failure; Edema; CHF

Outcome Measures

Primary Outcomes (2)

• Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session

  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.

  In-Hospital Phase [2-10 days]

• Incidences of Device and treatment-related AEs and SAEs and symptomatic changes in vital signs

  Symptomatic changes in vital signs including incidences of symptomatic hypotension and a decrease of more than 50% in eGFR compared to baseline

  up to 70 days

Secondary Outcomes (6)

• Change in body weight

  Up to 60 days

• Change of diuretic therapy

  Up to 60 days

• Changes in NT-ProBNP levels

  Up to 60 days

• Rate of Hospitalizations or emergency visits for decompensated heart failure

  Up to 60 days

• Changes in Renal function

  up to 60 days

Study Arms (1)

Patients are hospitalized with chronic heart failure symptoms and fluid overloaded

EXPERIMENTAL

Phase 1: 'In Hospital' Phase: chronic heart failure (CHF) patients are enrolled in the study when admitted to the hospital with fluid overload. Study procedures performed, alongside diuretic therapy, in the hospital. Phase 2: 'At Home' Phase: Upon investigator's decision at discharge, the patients are enrolled in the second phase of the study for additional treatment sessions at home.

Device: The AquaPass System

Interventions

The AquaPass System DEVICE

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.

Patients are hospitalized with chronic heart failure symptoms and fluid overloaded

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Subject was hospitalized for worsening of chronic heart failure with fluid overload.
• Recruitment with expectation for at least 2 additional days in hospital.
• Subject has composite congestion score ≥3.
• Baseline systolic blood pressure ≥100.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AquaPass Medical Ltd.: lead

Study Sites (2)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Rabin medical center, campus Belinson

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Doron Aronson, Prof.

  Rambam MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: May 6, 2023
• Study Start: February 20, 2022
• Primary Completion: August 14, 2023
• Study Completion: December 12, 2023
• Last Updated: December 12, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)