Heart Failure Clinical Trial

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

372

Study ID:

NCT05318105

Recruitment Status:

Recruiting

Sponsor:

Nuwellis, Inc.

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There are 12 Locations for this study

See Locations Near You

Banner Health
Tucson Arizona, 85721, United States More Info
Dalise Dai
Contact
312-237-5891
[email protected]
Radha Gopalan, MD
Principal Investigator
Sharp Memorial Hospital, San Diego Cardiac Center
San Diego California, 92123, United States More Info
Emma Burkhalter, RN, MSN
Contact
858-244-6889
[email protected]
Diana Nguyen
Contact
[email protected]
Brian Jaski, MD
Principal Investigator
University of California San Francisco
San Francisco California, 94143, United States More Info
Cassie Nguyen
Contact
415-353-9124
[email protected]
Liviu Klein, MD
Principal Investigator
BayCare Medical Group, Morton Plant
Clearwater Florida, 33756, United States More Info
Sherry McLean
Contact
727-723-6527
[email protected]
Leslie Miller, MD
Principal Investigator
St. Joseph's Hospital
Tampa Florida, 33614, United States More Info
Karen Herring, RN
Contact
813-875-9000
[email protected]
Daniel Dries, MD
Principal Investigator
University of Kentucky
Lexington Kentucky, 40536, United States More Info
Jennifer Isaacs
Contact
859-323-4738
[email protected]
Andrew Kolodziej, MD
Principal Investigator
The Mount Sinai Hospital
New York New York, 10029, United States More Info
Kathryn Bass
Contact
212-241-3149
[email protected]
Samantha Ortiz Muriel
Contact
212-241-4580
[email protected]
Umesh Gidwani, MD
Principal Investigator
Northwell Health
New York New York, 10075, United States More Info
Alana Gulliver
Contact
212-434-3802
[email protected]
Sirish Vullaganti, MD
Principal Investigator
The Ohio State University
Columbus Ohio, 43215, United States More Info
maeve McLoughlin, MPH
Contact
614-292-4084
[email protected]
Sitaramesh Emani, MD
Principal Investigator
Abington Jefferson Health
Abington Pennsylvania, 19001, United States More Info
Amanda Merrill, RN
Contact
215-481-4661
[email protected]
Colleen Marchand, RN
Contact
215-481-4661
[email protected]
Donald Haas, MD
Principal Investigator
Jackson Madison County General Hospital
Jackson Tennessee, 38301, United States More Info
Mary Harris, RN
Contact
731-541-6910
[email protected]
Shree Mulay, MD
Principal Investigator
Baylor Scott & White Research Institute
Dallas Texas, 75207, United States More Info
Amy Watts
Contact
254-724-1392
[email protected]
Jamie Hernandez Montfort, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

372

Study ID:

NCT05318105

Recruitment Status:

Recruiting

Sponsor:


Nuwellis, Inc.

How clear is this clinincal trial information?

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