RECRUITING

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-06-28
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05318105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Man, or non-pregnant woman
  3. * Admitted to the hospital with a diagnosis of acute decompensated heart failure
  4. * On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission
  5. * Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.)
  6. * Provide written informed consent
  1. * New diagnosis of heart failure
  2. * Acute coronary syndromes
  3. * Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment
  4. * Contraindications to systemic anticoagulation
  5. * Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days
  6. * Sepsis or ongoing systemic infection
  7. * Active myocarditis
  8. * Constrictive pericarditis or restrictive cardiomyopathy
  9. * Severe aortic stenosis
  10. * Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival

Contacts and Locations

Study Contact

Megan Cotts
CONTACT
952-345-4217
megan.cotts@nuwellis.com

Principal Investigator

Sean Pinney, MD
PRINCIPAL_INVESTIGATOR
Mount Sinai Morningside
Maria DeVita, MD, FASN
PRINCIPAL_INVESTIGATOR
Lenox Hill Hospital

Study Locations (Sites)

Banner Health
Tucson, Arizona, 85721
United States
MemorialCare, Long Beach Medical Center
Long Beach, California, 90806
United States
Sharp Memorial Hospital, San Diego Cardiac Center
San Diego, California, 92123
United States
University of California San Francisco
San Francisco, California, 94143
United States
BayCare Medical Group, Morton Plant
Clearwater, Florida, 33756
United States
St. Joseph's Hospital
Tampa, Florida, 33614
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Henry Ford Health
Detroit, Michigan, 48202
United States
Mount Sinai Morningside
New York, New York, 10025
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
Northwell Health
New York, New York, 10075
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
The Ohio State University
Columbus, Ohio, 43215
United States
Abington Jefferson Health
Abington, Pennsylvania, 19001
United States
Jackson Madison County General Hospital
Jackson, Tennessee, 38301
United States
Baylor Scott & White Research Institute
Dallas, Texas, 75207
United States
Sentara Norfolk General Heart Hospital
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Nuwellis, Inc.

  • Sean Pinney, MD, PRINCIPAL_INVESTIGATOR, Mount Sinai Morningside
  • Maria DeVita, MD, FASN, PRINCIPAL_INVESTIGATOR, Lenox Hill Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-28
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2022-06-28
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • Heart failure
  • Fluid overload

Additional Relevant MeSH Terms

  • Heart Failure (for Example, Fluid Overload)