Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

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.

Conditions

Heart Failure (for Example, Fluid Overload)

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Study Overview

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Study Details

Study overview

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.

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

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Condition
Heart Failure (for Example, Fluid Overload)
Intervention / Treatment

-

Contacts and Locations

Tucson

Banner Health, Tucson, Arizona, United States, 85721

Long Beach

MemorialCare, Long Beach Medical Center, Long Beach, California, United States, 90806

San Diego

Sharp Memorial Hospital, San Diego Cardiac Center, San Diego, California, United States, 92123

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Clearwater

BayCare Medical Group, Morton Plant, Clearwater, Florida, United States, 33756

Tampa

St. Joseph's Hospital, Tampa, Florida, United States, 33614

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

Detroit

Henry Ford Health, Detroit, Michigan, United States, 48202

New York

Mount Sinai Morningside, New York, New York, United States, 10025

New York

The Mount Sinai Hospital, New York, New York, United States, 10029

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nuwellis, Inc.,

Sean Pinney, MD, PRINCIPAL_INVESTIGATOR, Mount Sinai Morningside

Maria DeVita, MD, FASN, PRINCIPAL_INVESTIGATOR, Lenox Hill Hospital

Study Record Dates

2025-10-30