← Back to Search

Device

AquaPass System for Heart Failure (REFORM-HF Trial)

N/A
Waitlist Available
Led By Scott C Feitell, DO
Research Sponsored by AquaPass Medical Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patient with severe peripheral arterial disease
Patients with cystic fibrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Summary

This trial is testing a new technology called AquaPass to help heart failure patients with fluid overload. Patients will wear a special suit that helps remove excess fluids through their sweat. The study aims to see if

Who is the study for?
This trial is for adults aged 21-79 with chronic heart failure or kidney disease, who have fluid buildup despite taking diuretics. They must have a specific blood marker level (NT-proBNP ≥600 pg/mL), stable medication use in the past week, and be able to consent. Those recently hospitalized for heart failure or on conflicting trials can't join.
What is being tested?
The REFORM-HF study tests the AquaPass System, a wearable suit designed to help remove excess body fluids through sweat in patients with heart failure. The goal is to see if it can eliminate an extra 500mL of fluid alongside usual medications either at home or outpatient settings.
What are the potential side effects?
Potential side effects are not explicitly listed but may include skin irritation from the suit, discomfort during use, and possible imbalance in body salts due to increased sweating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 79 years old.
Select...
I have severe heart failure or kidney disease stage 2+ and my current medications are not managing my fluid retention.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe artery problems in my legs.
Select...
I have cystic fibrosis.
Select...
I currently have an active infection.
Select...
I have been diagnosed with severe narrowing of my heart's aortic or mitral valve.
Select...
I have visible skin issues (like wounds or infections) on my body, not including my face.
Select...
My kidney function is very low.
Select...
I have had a heart transplant, am on the transplant list, or have an LVAD.
Select...
My heart failure has recently worsened, needing intensive support.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AquaPass Performance Evaluation
Secondary outcome measures
AquaPass Safety Evaluation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AquaPassExperimental Treatment1 Intervention
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
Group II: ControlActive Control1 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.

Find a Location

Who is running the clinical trial?

AquaPass Medical Ltd.Lead Sponsor
4 Previous Clinical Trials
78 Total Patients Enrolled
Scott C Feitell, DOPrincipal InvestigatorRochester Regional Health
~10 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top