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Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

NCT05318105 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2025-05-15

No results posted yet for this 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.

Conditions

  • Heart Failure (for Example, Fluid Overload)
  • Heart Failure
  • Fluid Overload

Interventions

DEVICE

Aquadex Smartflow® System

ultrafiltration

DRUG

IV Loop Diuretics

diuretics

Sponsors & Collaborators

  • Nuwellis, Inc.

    lead INDUSTRY

Principal Investigators

  • Sean Pinney, MD · Mount Sinai Morningside

  • Maria DeVita, MD, FASN · Lenox Hill Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318105 on ClinicalTrials.gov