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Device

AquaPass System for Heart Failure (REFORM-HF Trial)

N/A

Recruiting

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

No Placebo-Only Group

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

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I am between 21 and 79 years old.

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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:

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I have severe artery problems in my legs.

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I have cystic fibrosis.

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I currently have an active infection.

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I have been diagnosed with severe narrowing of my heart's aortic or mitral valve.

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I have visible skin issues (like wounds or infections) on my body, not including my face.

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My kidney function is very low.

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I have had a heart transplant, am on the transplant list, or have an LVAD.

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My heart failure has recently worsened, needing intensive support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AquaPass Performance Evaluation

Secondary study objectives

AquaPass Safety Evaluation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 10Eligibility criteria met