Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Nuwellis, Inc.
- Study ID
- NCT05318105
- Status
- Recruiting
Conditions
- Fluid Overload
- Heart Failure
- Heart Failure (for Example, Fluid Overload)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aquadex Smartflow® System — DEVICEultrafiltration
- IV Loop Diuretics — DRUGdiuretics
Study Details
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.
Key Dates
- Start date
- Jun 28, 2022
- Status verified
- May 2025
- Primary completion
- Sep 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 372 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Aquadex ultrafiltration therapy
- Active Comparator: IV loop diuretics
Primary Outcome Measure
Time to first heart failure (HF) event [ Time Frame: within 30 days ]
Central Contacts
- Megan Cotts952-345-4217
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Banner Health | Tucson | Arizona | 85721 | Radha Gopalan, MD (PRINCIPAL_INVESTIGATOR) |
| MemorialCare, Long Beach Medical Center | Long Beach | California | 90806 | Morgan Ebbert Andrew Yoon, MD (PRINCIPAL_INVESTIGATOR) |
| Sharp Memorial Hospital, San Diego Cardiac Center | San Diego | California | 92123 | Diana Nguyen Brian Jaski, MD (PRINCIPAL_INVESTIGATOR) |
| University of California San Francisco | San Francisco | California | 94143 | - |
| BayCare Medical Group, Morton Plant | Clearwater | Florida | 33756 | - |
| St. Joseph's Hospital | Tampa | Florida | 33614 | - |
| University of Kentucky | Lexington | Kentucky | 40536 | Andrew Kolodziej, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Health | Detroit | Michigan | 48202 | Kelsey Neaton Jennifer Cowger, MD (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai Morningside | New York | New York | 10025 | Katharine Idrissi Ashish Correa, MBBS (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | New York | New York | 10075 | Sirish Vullaganti, MD (PRINCIPAL_INVESTIGATOR) |
| The Mount Sinai Hospital | New York | New York | 10029 | Umesh Gidwani, MD (PRINCIPAL_INVESTIGATOR) |
| The Christ Hospital | Cincinnati | Ohio | 45219 | Karen Federle Sitaramesh Emani, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University | Columbus | Ohio | 43215 | Sitaramesh Emani, MD (PRINCIPAL_INVESTIGATOR) |
| Abington Jefferson Health | Abington | Pennsylvania | 19001 | Donald Haas, MD (PRINCIPAL_INVESTIGATOR) |
| Jackson Madison County General Hospital | Jackson | Tennessee | 38301 | Shree Mulay, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott & White Research Institute | Dallas | Texas | 75207 | Jamie Hernandez Montfort, MD (PRINCIPAL_INVESTIGATOR) |
| Sentara Norfolk General Heart Hospital | Norfolk | Virginia | 23507 | Kelly Jordan Ashley Williams Amin Yehya, MD (PRINCIPAL_INVESTIGATOR) |
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