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Ultrafiltration vs IV Diuretics for Heart Failure (REVERSE-HF Trial)

N/A
Recruiting
Led By Sean Pinney, MD
Research Sponsored by Nuwellis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Admitted to the hospital with a diagnosis of acute decompensated heart failure
Must not have
Contraindications to systemic anticoagulation
Active myocarditis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether a specific type of heart failure treatment is better than another common treatment.

Who is the study for?
This trial is for adults over 18 with worsening heart failure who are hospitalized, have been on oral loop diuretics, and show signs of fluid overload like edema. It's not for those with severe diseases expected to affect survival within 90 days, conditions preventing follow-up, contraindications to blood thinners, new heart failure diagnosis, recent heart attacks or infections.
What is being tested?
The REVERSE-HF study compares two treatments in patients with worsening heart failure: the Aquadex Smartflow® System which removes excess fluid from the body through ultrafiltration and traditional IV loop diuretics that help eliminate fluid via urine.
What are the potential side effects?
Potential side effects may include issues related to fluid removal such as low blood pressure or imbalances in electrolytes (like potassium), reactions at the site where fluids are removed or administered, and possible complications from anticoagulants used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am hospitalized for worsening heart failure.
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I have signs of fluid overload, like swelling or gaining over 10 pounds from fluid.
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I am a man or a woman not currently pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take blood thinners due to health reasons.
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I have inflammation of the heart muscle.
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I do not have an ongoing infection or sepsis.
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I have had a recent heart attack or severe chest pain.
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I have recently been diagnosed with heart failure.
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I have a heart condition that limits its ability to stretch and fill.
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I have been diagnosed with severe narrowing of the aortic valve.
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I do not have a severe illness that could extend my hospital stay or cause death within 3 months.
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My creatinine levels are high, or I am planning to start dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to first heart failure (HF) event
Secondary study objectives
Win ratio analysis

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: Aquadex ultrafiltration therapyExperimental Treatment1 Intervention
Group II: IV loop diureticsActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Nuwellis, Inc.Lead Sponsor
10 Previous Clinical Trials
792 Total Patients Enrolled
Sean Pinney, MDPrincipal InvestigatorMount Sinai Morningside
1 Previous Clinical Trials
46 Total Patients Enrolled
Maria DeVita, MD, FASNPrincipal InvestigatorLenox Hill Hospital

Media Library

Aquadex Smartflow® System Clinical Trial Eligibility Overview. Trial Name: NCT05318105 — N/A
Congestive Heart Failure Research Study Groups: IV loop diuretics, Aquadex ultrafiltration therapy
Congestive Heart Failure Clinical Trial 2023: Aquadex Smartflow® System Highlights & Side Effects. Trial Name: NCT05318105 — N/A
Aquadex Smartflow® System 2023 Treatment Timeline for Medical Study. Trial Name: NCT05318105 — N/A
~80 spots leftby Jul 2025
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