Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry

NCT06401109 | Not Yet Recruiting DMC

• 1 other identifier: AQP-CLP-044
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Heart Failure; Fluid Overload; Acute Decompensated Heart Failure; Edema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Incidence of worsening renal function

  30 days

• Fluid Overload Related Hospitalizations

  30 days

• Changes in congestion score

  30 days

• Changes in Diuretics Dose

  30 days

• Change of quality of life

  30 days

Study Arms (1)

AquaPass

EXPERIMENTAL

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

Interventions

AquaPass DEVICE

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.

AquaPass

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: May 2, 2024
• First Posted: May 6, 2024
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 6, 2024

Record last verified: 2024-05