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Ultrafiltration Versus IV Diuretics in Worsening Heart Failure (REVERSE-HF)

Primary Purpose

Heart Failure (for Example, Fluid Overload)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquadex Smartflow® System
IV Loop Diuretics
Sponsored by
Nuwellis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure (for Example, Fluid Overload) focused on measuring Heart failure, Fluid overload

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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

Sites / Locations

  • Banner HealthRecruiting
  • Sharp Memorial Hospital, San Diego Cardiac CenterRecruiting
  • University of California San FranciscoRecruiting
  • BayCare Medical Group, Morton PlantRecruiting
  • St. Joseph's HospitalRecruiting
  • University of KentuckyRecruiting
  • The Mount Sinai HospitalRecruiting
  • Northwell HealthRecruiting
  • The Ohio State UniversityRecruiting
  • Abington Jefferson HealthRecruiting
  • Jackson Madison County General HospitalRecruiting
  • Baylor Scott & White Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aquadex ultrafiltration therapy

IV loop diuretics

Arm Description

Outcomes

Primary Outcome Measures

All-cause mortality
Heart failure (HF) events
HF rehospitalization or unplanned use of Aquadex ultrafiltration therapy, IV loop diuretics, or vasoactive medications
Time to first Heart Failure (HF) event

Secondary Outcome Measures

Full Information

First Posted
March 10, 2022
Last Updated
July 10, 2023
Sponsor
Nuwellis, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05318105
Brief Title
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
Acronym
REVERSE-HF
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuwellis, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure (for Example, Fluid Overload)
Keywords
Heart failure, Fluid overload

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aquadex ultrafiltration therapy
Arm Type
Experimental
Arm Title
IV loop diuretics
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Aquadex Smartflow® System
Intervention Description
ultrafiltration
Intervention Type
Drug
Intervention Name(s)
IV Loop Diuretics
Intervention Description
diuretics
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
within 90 days
Title
Heart failure (HF) events
Description
HF rehospitalization or unplanned use of Aquadex ultrafiltration therapy, IV loop diuretics, or vasoactive medications
Time Frame
within 30 days
Title
Time to first Heart Failure (HF) event
Time Frame
within 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Cease
Phone
952-345-4217
Email
megan.cease@nuwellis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Pinney, MD
Organizational Affiliation
Mount Sinai Morningside
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria DeVita, MD, FASN
Organizational Affiliation
Lenox Hill Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalise Dai
Phone
312-237-5891
Email
daliseshatz@arizona.edu
First Name & Middle Initial & Last Name & Degree
Radha Gopalan, MD
Facility Name
Sharp Memorial Hospital, San Diego Cardiac Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Burkhalter, RN, MSN
Phone
858-244-6889
Email
eburkhalter@sdcardiac.com
First Name & Middle Initial & Last Name & Degree
Diana Nguyen
Email
dnguyen@sdcardiac.com
First Name & Middle Initial & Last Name & Degree
Brian Jaski, MD
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassie Nguyen
Phone
415-353-9124
Email
cassie.nguyen@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Liviu Klein, MD
Facility Name
BayCare Medical Group, Morton Plant
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry McLean
Phone
727-723-6527
Email
Sherry.McLean@baycare.org
First Name & Middle Initial & Last Name & Degree
Leslie Miller, MD
Facility Name
St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Herring, RN
Phone
813-875-9000
Email
Karen.Herring@baycare.org
First Name & Middle Initial & Last Name & Degree
Daniel Dries, MD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Isaacs
Phone
859-323-4738
Email
jennifer.isaacs@uky.edu
First Name & Middle Initial & Last Name & Degree
Andrew Kolodziej, MD
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Bass
Phone
212-241-3149
Email
Kathryn.Bass@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Samantha Ortiz Muriel
Phone
212-241-4580
Email
Samantha.OrtizMuriel@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Umesh Gidwani, MD
Facility Name
Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alana Gulliver
Phone
212-434-3802
Email
agulliver@northwell.edu
First Name & Middle Initial & Last Name & Degree
Sirish Vullaganti, MD
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
maeve McLoughlin, MPH
Phone
614-292-4084
Email
Maeve.McLoughlin@osumc.edu
First Name & Middle Initial & Last Name & Degree
Sitaramesh Emani, MD
Facility Name
Abington Jefferson Health
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Merrill, RN
Phone
215-481-4661
Email
amanda.merrill@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Colleen Marchand, RN
Phone
215-481-4661
Email
colleen.marchand@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Donald Haas, MD
Facility Name
Jackson Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Harris, RN
Phone
731-541-6910
Email
mary.harris@wth.org
First Name & Middle Initial & Last Name & Degree
Shree Mulay, MD
Facility Name
Baylor Scott & White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Watts
Phone
254-724-1392
Email
Amy.Watts@BSWHealth.org
First Name & Middle Initial & Last Name & Degree
Jamie Hernandez Montfort, MD

12. IPD Sharing Statement

Learn more about this trial

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

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