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: 4

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

Conditions

Chronic Heart Failure; CKD Stage 3

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 in the outpatient settings or at home and supervised by a 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, body weight, and quality of life. 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 - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AquaPass Medical Ltd.: lead

Study Sites (4)

Rochester Regional Health

Rochester, New York, 14621, United States

RECRUITING

Cone Health Advanced Heart Failure Clinic at Moses Cone

Greensboro, North Carolina, 27401, 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

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-patient-controlled, pivotal trial, enrolling patients with decompensated heart failure and/or CKD stage 2-3 inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥40 mg furosemide or equivalent.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: September 5, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 29, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IL (2); US (2)