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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Within 48 hours of inpatient stay OR ED presentation for HF with plans for admission OR observation stay/short-stay hospitalization for HF

Expected to require at least 24 additional hours of IV diuretics

Adequate home environment for self-care

Disqualifiers

Cognitive impairment preventing informed consent

Geographic barriers to follow-up

Pregnancy or breastfeeding

IV furosemide requirement >250mg/day

Trial design

Treatments tested in this trial

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

Treatment groups

250 Participants
are divided into 2 treatment groups