Trials / Recruiting
RecruitingNCT05318105
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 372 (estimated)
- Sponsor
- Nuwellis, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aquadex Smartflow® System | ultrafiltration |
| DRUG | IV Loop Diuretics | diuretics |
Timeline
- Start date
- 2022-06-28
- Primary completion
- 2026-09-30
- Completion
- 2026-12-31
- First posted
- 2022-04-08
- Last updated
- 2025-05-15
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05318105. Inclusion in this directory is not an endorsement.