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NCT05318105 · ClinicalTrials.gov registry record · NA

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

A NA study of Heart Failure and Fluid Overload, sponsored by Nuwellis.

Recruiting
Registry status
NA
Development phase
372
Enrollment target
17
Study locations

NCT05318105: Recruiting NA study of Heart Failure and Fluid Overload, sponsored by Nuwellis.

NCT05318105 is a NA study of Heart Failure and Fluid Overload that is actively recruiting participants, run by Nuwellis. The registered enrollment target is 372 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (82% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05318105, a NA study of Heart Failure and Fluid Overload, is actively recruiting participants, sponsored by Nuwellis.

RECRUITING
Registry status
NA
Development phase
372 participants
Enrollment target
17
Study locations

Study 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.

Primary Outcome

Heart Failure (HF) event defined as any HF rehospitalization or unplanned use of IV loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting.

Interventions

  • DEVICE Aquadex Smartflow® System
  • DRUG IV Loop Diuretics

Study Locations (17)

California

  • MemorialCare, Long Beach Medical Center - Long Beach
  • Sharp Memorial Hospital, San Diego Cardiac Center - San Diego
  • University of California San Francisco - San Francisco

New York

  • Mount Sinai Morningside - New York
  • The Mount Sinai Hospital - New York
  • Northwell Health - New York

Florida

  • BayCare Medical Group, Morton Plant - Clearwater
  • St. Joseph's Hospital - Tampa

Ohio

  • The Christ Hospital - Cincinnati
  • The Ohio State University - Columbus

Arizona

  • Banner Health - Tucson

Kentucky

  • University of Kentucky - Lexington

Michigan

  • Henry Ford Health - Detroit

Pennsylvania

  • Abington Jefferson Health - Abington

Trial Details

FieldValue
Enrollment Target 372 participants
Start Date 2022-06-28
Est. Completion 2026-12-31
Phase NA
Nuwellis

7 total trials

What NCT05318105 shows while recruiting

NCT05318105 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (82% lower).

The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Aquadex Smartflow® System is the first listed.

NCT05318105 lists 17 locations in 11 states (California, New York, Florida).

Frequently Asked Questions

What is clinical trial NCT05318105 about?

NCT05318105 is a clinical study titled "Ultrafiltration Versus IV Diuretics in Worsening Heart Failure". 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.

What is the current status of trial NCT05318105?

This trial is currently recruiting. It is a NA study. The enrollment target is 372 participants. The study started on 2022-06-28. Estimated completion is 2026-12-31.

What conditions does trial NCT05318105 study?

This clinical trial studies the following conditions: Heart Failure, Fluid Overload, Heart Failure (for Example, Fluid Overload).

What interventions are being tested in trial NCT05318105?

The interventions under investigation include: Aquadex Smartflow® System (DEVICE), IV Loop Diuretics (DRUG).

Who is sponsoring clinical trial NCT05318105?

This trial is sponsored by Nuwellis, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05318105 being conducted?

This trial has 17 study locations across Arizona, California, Florida, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Heart Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05318105's enrollment target sits among peer trials

372 120th of 397 higher than 278 of 397 other Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05318105, the US trial registry maintained by the National Library of Medicine. NCT05318105 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.