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Purpose

The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years or older - Man, or non-pregnant woman - Admitted to the hospital with a primary diagnosis of acute decompensated heart failure - On regularly prescribed oral loop diuretics prior to admission - Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.) - Provide written informed consent

Exclusion Criteria

  • New diagnosis of heart failure - Acute coronary syndromes - Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment - Contraindications to systemic anticoagulation - Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days - Sepsis or ongoing systemic infection - Active myocarditis - Constrictive pericarditis or restrictive cardiomyopathy - Severe aortic stenosis - Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Aquadex ultrafiltration therapy
  • Device: Aquadex Smartflow® System
    ultrafiltration
Active Comparator
IV loop diuretics
  • Drug: IV Loop Diuretics
    diuretics

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Jennifer Isaacs
859-323-4738
jennifer.isaacs@uky.edu

More Details

NCT ID
NCT05318105
Status
Recruiting
Sponsor
Nuwellis, Inc.

Study Contact

Megan Cease
952-345-4217
megan.cease@nuwellis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.