Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Liviu Klein, MD
Headshot of Liviu Klein
Liviu Klein

Description

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.

Official Title

A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload

Keywords

Heart Failure (for Example, Fluid Overload), Heart failure, Fluid overload, Diuretics, Sodium Potassium Chloride Symporter Inhibitors, Aquadex Smartflow® System, IV Loop Diuretics, Aquadex ultrafiltration therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • BayCare Medical Group, Morton Plant accepting new patients
    Clearwater Florida 33756 United States

Lead Scientist at UCSF

  • Liviu Klein, MD
    My clinical interests are heart failure and cardiac arrhythmias in patients with heart failure. Having advanced training in both heart failure and electrophysiology, I practice an integrated approach in treating patients with heart failure and cardiac arrhythmias. I am also interested in cardiac recovery using electrical (i.e. cardiac resynchronization) and mechanical (i.e.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nuwellis, Inc.
ID
NCT05318105
Study Type
Interventional
Participants
Expecting 372 study participants
Last Updated