← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days
Awards & highlights

REVERSE-HF Trial 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.Check my eligibility
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.See study design
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.

REVERSE-HF Trial Eligibility Criteria

Inclusion Criteria

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

REVERSE-HF Trial 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

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

REVERSE-HF 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
9 Trials studying Heart Failure
695 Patients Enrolled for Heart Failure
Sean Pinney, MDPrincipal InvestigatorMount Sinai Morningside
1 Previous Clinical Trials
46 Total Patients Enrolled
1 Trials studying Heart Failure
46 Patients Enrolled for Heart Failure
Maria DeVita, MD, FASNPrincipal InvestigatorLenox Hill Hospital

Media Library

Aquadex Smartflow® System Clinical Trial Eligibility Overview. Trial Name: NCT05318105 — N/A
Heart Failure Research Study Groups: IV loop diuretics, Aquadex ultrafiltration therapy
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of this investigation's participant pool?

"To make this clinical trial a success, 372 eligible participants are required. Individuals can apply at Sharp Memorial Hospital, San Diego Cardiac Center in San Diego or BayCare Medical Group's Morton Plant facility in Clearwater, Florida."

Answered by AI

Are there any open slots to join this experiment?

"According to the clinicaltrials.gov portal, this research is currently in search of participants with a start date of June 28th 2022 and an edit date as recent as November 30th 2022."

Answered by AI

How many locations are hosting this scientific experiment?

"This trial is presently happening in 5 different clinics, including those situated in San Diego, Clearwater and San Francisco. For the sake of convenience, it might be ideal to pick a venue that is close by when choosing which clinic to attend for participation."

Answered by AI
~161 spots leftby Jul 2025