Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System

NCT06360380 | Recruiting DMC FDA Device

• 1 other identifier: AQP-CLP-004
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 10

Brief Summary

The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure. Patients will wear a lightweight suit that helps remove excess fluids through their sweat. The investigators want to see if the AQUAPASS system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics. Participants will be treated in the hospital or in the outpatient clinic.

Conditions

CKD Stage 3; Chronic Heart Failure

Keywords

Aquapass; Sweat Enhancement; Fluid removal; CHF

Outcome Measures

Primary Outcomes (1)

• AQUAPASS Performance Evaluation

  Average Net Fluid Loss calculated as the difference in weight between pre- and post-AQUAPASS treatment sessions, in comparison to the Control Day observation. Total Average Net Fluid Loss during the Treatment Phase should be ≥ 500gr. as compared to the Total Average Net Fluid Loss during the Control Phase.

  5 days

Secondary Outcomes (1)

• AQUAPASS Safety Evaluation

  6 hours

Study Arms (2)

AquaPass

EXPERIMENTAL

An AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff

Device: AquaPass System

Control

NO INTERVENTION

An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, and body weight. These data will serve as a control for the efficacy primary endpoint comparison.

Interventions

AquaPass System DEVICE

a treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis

AquaPass

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥21 years and \< 80 years
• Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic .
• No change in diuretic dosage in the past 5 days
• Subjects with eGFR between 15-89 mL/min/1.73m2
• Baseline NT-proBNP ≥600 pg/mL
• Baseline systolic blood pressure ≥100 mmHg
• Subject is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
• Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study

You may not qualify if:

• Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .
• Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure
• Known allergy to Polyester or Thermoplastic polyurethane (TPU)
• Subject with severe peripheral arterial disease
• Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.
• Subject with known hypothalamic disorders
• Subject with known hypohidrosis disorders
• Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.)
• Subject with cystic fibrosis
• Subject with active infections
• Inability or unwillingness to comply with the study requirements
• Subjects with unstable electrolytes or acid-base balance (as per investigator's discretion)
• Known Severe aortic valve or mitral valve stenosis
• History of a heart transplant or actively listed for a heart transplant
• Implanted left ventricular assist device (LVAD) or implant anticipated in \<3 months

Sponsors & Collaborators

• AquaPass Medical Ltd.: lead

Study Sites (10)

UC San Diego Health-Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

RECRUITING

UC San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Northwell Health- Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Rochester Regional Health

Rochester, New York, 14621, United States

RECRUITING

Mission Hospital

Asheville, North Carolina, 28801, United States

RECRUITING

Cone Health Advanced Heart Failure Clinic at Moses Cone

Greensboro, North Carolina, 27401, United States

RECRUITING

Austin Heart Hospital

Austin, Texas, 78705, United States

RECRUITING

Rambam Medical Campus

Haifa, 3109601, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

Study Officials

• Scott C Feitell, DO

  Rochester Regional Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott C Feitell, DO

CONTACT

(585) 442 5320; scott.feitell@rochesterregional.org

Julie Mooney, RN

CONTACT

585-738-3409; julie.mooney@rochesterregional.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, single-arm, within-subject-controlled, pivotal trial, enrolling subjects with decompensated heart failure inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥80 mg furosemide or equivalent loop diuretics.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: August 12, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

US (8); IL (2)