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

Conditions

• Acute Decompensated Heart Failure
• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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 Dates

Start date

Aug 31, 2026

Status verified

May 2026

Primary completion

Aug 1, 2028

Completion

Sep 1, 2028

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Early Discharge with Subcutaneous Furosemide
  The practice group randomized to early discharge with subcutaneous furosemide home infusion will begin initiation of subcutaneous furosemide (LASIX-ONYU) with a SQIN-Infusor device prior to discharge from the hospital. Dosing will be based on pre-admission oral furosemide requirements. Those with a home dose of ≤80mg/day oral furosemide will receive 80mg subcutaneous once daily at home and those with \>80mg/day oral furosemide will receive 80mg subcutaneous twice daily at home.
• No Intervention: Usual Care
  Usual inpatient care with IV furosemide. Discharge timing determined by treating physician per standard practice.

Primary Outcome Measure

Days alive and out of the hospital [ Time Frame: 30-day ]

Central Contacts

• Ambarish Pandey, MD
  214-645-2101
  [email protected]
• Neil Keshvani, MD
  214-6485198
  [email protected]

Locations (2)

Find similar trials in Dallas, TX

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