Clinical trial NCT05318105: Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
Official title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure (for Example, Fluid Overload)
Heart Failure
Fluid Overload
Keywords: Heart failure
Fluid overload
Lead sponsor: Nuwellis, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* 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:

* 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

Primary outcomes:
measure: Time to first heart failure (HF) event
timeFrame: within 30 days
Secondary outcomes:
measure: Win ratio analysis
timeFrame: within 30 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner Health
state: Arizona
city: Long Beach
country: United States
facility: MemorialCare, Long Beach Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital, San Diego Cardiac Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Clearwater
country: United States
facility: BayCare Medical Group, Morton Plant
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: New York
country: United States
facility: Mount Sinai Morningside
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Abington
country: United States
facility: Abington Jefferson Health
state: Pennsylvania
city: Jackson
country: United States
facility: Jackson Madison County General Hospital
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Heart Hospital
state: Virginia
Study officials:
affiliation: Mount Sinai Morningside
name: Sean Pinney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Hill Hospital
name: Maria DeVita, MD, FASN
role: PRINCIPAL_INVESTIGATOR
References: