Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
NCT ID: NCT05318105
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
372 participants
INTERVENTIONAL
2022-06-28
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aquadex ultrafiltration therapy
Aquadex Smartflow® System
ultrafiltration
IV loop diuretics
IV Loop Diuretics
diuretics
Interventions
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Aquadex Smartflow® System
ultrafiltration
IV Loop Diuretics
diuretics
Eligibility Criteria
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Inclusion Criteria
* Man, or non-pregnant woman
* Admitted to the hospital with a diagnosis of acute decompensated heart failure
* On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) 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
* 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
18 Years
ALL
No
Sponsors
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Nuwellis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sean Pinney, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Morningside
Maria DeVita, MD, FASN
Role: PRINCIPAL_INVESTIGATOR
Lenox Hill Hospital
Locations
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Banner Health
Tucson, Arizona, United States
MemorialCare, Long Beach Medical Center
Long Beach, California, United States
Sharp Memorial Hospital, San Diego Cardiac Center
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
BayCare Medical Group, Morton Plant
Clearwater, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Henry Ford Health
Detroit, Michigan, United States
Mount Sinai Morningside
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Northwell Health
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Abington Jefferson Health
Abington, Pennsylvania, United States
Jackson Madison County General Hospital
Jackson, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Sentara Norfolk General Heart Hospital
Norfolk, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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McCallum W, Sarnak MJ. Cardiorenal Syndrome in the Hospital. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):933-945. doi: 10.2215/CJN.0000000000000064. Epub 2023 Jan 13.
Other Identifiers
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CLIN07687
Identifier Type: -
Identifier Source: org_study_id
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