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Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure

NCT07018297 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-04

No results posted yet for this study

Summary

This will be a prospective, cluster-randomized, crossover, non-inferiority trial of 250 participants within 48 hours of an inpatient admission for heart failure or emergency department presentation for heart failure with plans for admission or observation/short-stay hospitalization comparing early discharge using subcutaneous furosemide to standard inpatient care. Individual practice groups will serve as "clusters" and the unit of randomization. Each participating cluster will implement either the early discharge strategy using the intervention or standard care for initial two-month blocks, followed by a crossover to the alternate strategy. The primary outcome is days alive and out of hospital at 30 days.

Conditions

Interventions

COMBINATION_PRODUCT

Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor

Each practice group randomized to early discharge with subcutaneous furosemide will provide the patient with prefilled units of Lasix® ONYU furosemide injection containing 80 mg per 2.67 mL in a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor that will be used in conjunction with the reusable unit of the Lasix ONYU Infusor. Dosing based on pre-admission oral furosemide requirements: ≤80mg/day oral furosemide will be given 80mg subcutaneous once daily or \>80mg/day oral furosemide will be given 80mg subcutaneous twice daily. Dosing will be continued until clinical euvolemia is reached.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-01
Completion
2028-09-01
FDA Drug
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 NCT07018297 on ClinicalTrials.gov