REVERSE-HF: Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

• Sponsor: Nuwellis, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05318105
• Collaborator: (none)
• Enrollment: 372
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 30.1
• Patients Per Site: 186
• Patients Per Site Per Month: 6.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure (for Example, Fluid Overload)	Device: Aquadex Smartflow® System; Drug: IV Loop Diuretics	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 372 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
• Actual Study Start Date: Jun 28, 2022
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aquadex ultrafiltration therapy	Device: Aquadex Smartflow® System; ultrafiltration
Active Comparator: IV loop diuretics	Drug: IV Loop Diuretics; diuretics

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [within 90 days]

2. Heart failure (HF) events [within 30 days]

   HF rehospitalization or unplanned use of Aquadex ultrafiltration therapy, IV loop diuretics, or vasoactive medications

3. Time to first Heart Failure (HF) event [within 90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwell Health	New York	New York	United States	10075
2	Abington Jefferson Health	Abington	Pennsylvania	United States	19001

Sponsors and Collaborators

• Nuwellis, Inc.

Investigators

• Principal Investigator: Sean Pinney, MD, University of Chicago
• Principal Investigator: Maria DeVita, MD, FASN, Lenox Hill Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nuwellis, Inc.
• ClinicalTrials.gov Identifier: NCT05318105
• Other Study ID Numbers: CLIN07687
• First Posted: Apr 8, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• 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
• Keywords provided by Nuwellis, Inc.: Heart failure; Fluid overload
• Additional relevant MeSH terms: Heart Failure; Diuretics; Sodium Potassium Chloride Symporter Inhibitors

Study Results

No Results Posted as of Aug 22, 2022