Heart Failure Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

40

Study ID:

NCT06360380

Recruitment Status:

Not yet recruiting

Sponsor:

AquaPass Medical Ltd.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 4 Locations for this study

See Locations Near You

Rochester Regional Health
Rochester New York, 14621, United States More Info
Scott C Feitell, DO
Contact
585-442-5320
[email protected]
Cone Health Advanced Heart Failure Clinic at Moses Cone
Greensboro North Carolina, 27401, United States More Info
Aditya Sabharwal, DO
Contact
[email protected]
Rambam Medical Campus
Haifa , 31096, Israel More Info
Doron Aronson, MD, PhD
Contact
972-4-777-2342
[email protected]
Rabin Medical Center
Petach Tikva , 49100, Israel More Info
Tuvia Ben Gal, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

40

Study ID:

NCT06360380

Recruitment Status:

Not yet recruiting

Sponsor:


AquaPass Medical Ltd.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.