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 — DEVICE
    ultrafiltration
  • IV Loop Diuretics — DRUG
    diuretics

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

Locations (17)

FacilityCityStateZIPSite coordinators
Banner HealthTucsonArizona85721
Dalise Dai
312-237-5891
Radha Gopalan, MD (PRINCIPAL_INVESTIGATOR)
MemorialCare, Long Beach Medical CenterLong BeachCalifornia90806
Morgan Ebbert
Andrew Yoon, MD (PRINCIPAL_INVESTIGATOR)
Sharp Memorial Hospital, San Diego Cardiac CenterSan DiegoCalifornia92123
Emma Burkhalter, RN, MSN
858-244-6889
Diana Nguyen
Brian Jaski, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143-
BayCare Medical Group, Morton PlantClearwaterFlorida33756-
St. Joseph's HospitalTampaFlorida33614-
University of KentuckyLexingtonKentucky40536
Jennifer Isaacs
859-323-4738
Andrew Kolodziej, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford HealthDetroitMichigan48202
Kelsey Neaton
Jennifer Cowger, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai MorningsideNew YorkNew York10025
Katharine Idrissi
Ashish Correa, MBBS (PRINCIPAL_INVESTIGATOR)
Northwell HealthNew YorkNew York10075
Alana Gulliver
212-434-3802
Sirish Vullaganti, MD (PRINCIPAL_INVESTIGATOR)
The Mount Sinai HospitalNew YorkNew York10029
Kathryn Bass
212-241-3149
Umesh Gidwani, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Karen Federle
Sitaramesh Emani, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43215
maeve McLoughlin, MPH
614-292-4084
Sitaramesh Emani, MD (PRINCIPAL_INVESTIGATOR)
Abington Jefferson HealthAbingtonPennsylvania19001
Colleen Marchand, RN
215-481-4661
Donald Haas, MD (PRINCIPAL_INVESTIGATOR)
Jackson Madison County General HospitalJacksonTennessee38301
Mary Harris, RN
731-541-6910
Shree Mulay, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Research InstituteDallasTexas75207
Amy Watts
254-724-1392
Jamie Hernandez Montfort, MD (PRINCIPAL_INVESTIGATOR)
Sentara Norfolk General Heart HospitalNorfolkVirginia23507
Kelly Jordan
Ashley Williams
Amin Yehya, MD (PRINCIPAL_INVESTIGATOR)

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