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

Chronic Heart Failure Clinical Trial

— REFORM-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360380
• Other study ID #: AQP-CLP-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 3, 2024
• Est. completion date: December 29, 2024

Study information

• Verified date: May 2024
• Source: AquaPass Medical Ltd.
• Contact: Scott C Feitell, DO
• Phone: (585) 442 5320
• Email: scott.feitell[@]rochesterregional.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 29, 2024
• Est. primary completion date: November 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Heart Failure
• CKD Stage 3
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam Medical Campus	Haifa
Israel	Rabin Medical Center	Petach Tikva
United States	Cone Health Advanced Heart Failure Clinic at Moses Cone	Greensboro	North Carolina
United States	Rochester Regional Health	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
AquaPass Medical Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

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