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

REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients

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 select if to be treated at their home or in the outpatient clinic.

Study Overview

• Status: Recruiting
• Conditions: Chronic Heart Failure; CKD Stage 3
• Intervention / Treatment: Device: AquaPass System

Detailed Description

This study is being conducted to demonstrate the safety and effectiveness of the AquaPass System in reducing fluid overload in patients with decompensated heart failure and chronic kidney disease stage 2-3 who are not responding adequately or resistant to current medical treatment.

The study checks if patients' fluid loss as a result of taking diuretics medications is improved when using AquaPass in parallel to this treatment.

The evaluation of success is done by comparing participants' weight before and after the use of the AquaPass system, to evaluate if the system effectively removes excess fluids.

Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning.

The first visit will be observation only, without using AquaPass. This will serve as the baseline data. The investigators will compare the data of the AquaPass treatments with this baseline to measure the effectiveness of the system in removing access fluids.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott C Feitell, DO; Phone Number: (585) 442 5320; Email: Scott.Feitell@rochesterregional.org

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Campus
    • Contact: Doron Aronson, MD, PhD; Phone Number: 972-4-777-2342; Email: d_aronson@rambam.health.gov.il
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center
    • Contact: Tuvia Ben Gal, MD; Email: bengaltu@gmail.com
• United States
  • New York
    • Rochester, New York, United States, 14621
      • Recruiting
      • Rochester Regional Health
      • Contact: Scott C Feitell, DO; Phone Number: (585) 442 5320; Email: Scott.Feitell@rochesterregional.org
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Recruiting
      • Cone Health Advanced Heart Failure Clinic at Moses Cone
      • Contact: Aditya Sabharwal, DO; Email: aditya.sabharwal@conehealth.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥21 years and < 80 years
• Patient, with known decompensated heart failure and/or CKD stage 2 or more 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 40 mg furosemide or greater or the equivalent dose of another loop diuretic.
• Patients with no Heart Failure related hospitalization in the past 30 days
• No change in diuretic regimen in the past 7 days
• Baseline NT-proBNP ≥600 pg/mL
• Baseline systolic blood pressure ≥100 mmHg
• Patient 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
• Patient is not participating in any clinical investigation that may interfere with the data collection or the results of this study

Exclusion Criteria:

• Patient considered to be in the acute worsening of heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload.
• Patient has any known or visible lower body (non-facial) skin problems (open wounds, ulcers, infections)
• Patient with severe peripheral arterial disease
• Patient is pregnant or planning to become pregnant within the study period, or a lactating woman.
• Renal disease with eGFR <25 ml/min/1.73 m2
• Patients with known hypothalamic disorders
• Patients with known hypohidrosis disorders
• Patients with medical technology dependency (gastric (G) tubes, ventilators etc.)
• Patients with cystic fibrosis
• Patients with active infections
• Inability or unwillingness to comply with the study requirements
• Patients with unstable electrolytes or acid-base balance (per investigator's discretion)
• Known Severe aortic valve or mitral valve stenosis
• History of a heart transplant or actively listed for a heart transplant or LVAD
• Implanted left ventricular assist device or implant anticipated <3 months
• Patients with an active, malignant disease and whose life expectancy is < 6 months (per investigator's discretion)
• Unstable or acutely worsening cardiac or renal conditions (per investigator's discretion)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AquaPass; An AquaPass treatment session (up to 5-Hrs.) will be administered in the outpatient settings or at home and supervised by a certified study staff	Device: AquaPass System; 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
No Intervention: Control; An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, body weight, and quality of life. These data will serve as a control for the efficacy primary endpoint comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AquaPass Safety Evaluation	Incidence of device-related side effects - defined as events during or up to 1-Hour after device use	6 hours

Collaborators and Investigators

• Sponsor: AquaPass Medical Ltd.
• Investigators: Principal Investigator: Scott C Feitell, DO, Rochester Regional Health

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Estimated): January 3, 2025
• Study Completion (Estimated): January 29, 2025

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: CHF; Fluid removal; Aquapass; Sweat Enhancement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: AQP-CLP-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No