Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Starting soon · Phase 3
Conditions studied: Heart Failure, Acute Decompensated Heart Failure
In brief
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.
Key facts
- Study ID
- NCT07018297
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 250
- Starts
- 2026-08-01
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Patient or caregiver capable of operating subcutaneous delivery device
You may not qualify if…
- Cognitive impairment preventing informed consent
- Geographic barriers to follow-up
- Pregnancy or breastfeeding
- IV furosemide requirement >250mg/day
- eGFR <20 mL/min/1.73m2
- Type 1 myocardial infarction during index admission
- End-stage HF with receipt or consideration of heart transplant or LVAD or requiring inotropic or mechanical circulatory support
- Potassium <3.0 or >6.0 mmol/L or sodium <125 mmol/L
Where it is running
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Baylor Scott and White Health System — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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