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

NCT07018297 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: STU2025-0766
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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

Acute Decompensated Heart Failure; Heart Failure

Keywords

Subcutaneous Furosemide; Length of Stay (LOS); Hospitalization; Resource Allocation

Outcome Measures

Primary Outcomes (1)

• Days alive and out of the hospital

  Days alive and out of the hospital will be ascertained via retrospective review of the electronic health record.

  30-day

Secondary Outcomes (3)

• Change in Quality of Life

  Baseline, 14-day, and 30-day. The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where 0 is worst quality of life and 100 is best quality of life.

• Change in N-terminal pro B-type natriuretic peptide

  Baseline, 14-day, and 30-day

• Time-to-event for mortality and readmission

  30-day

Study Arms (2)

Early Discharge with Subcutaneous Furosemide

EXPERIMENTAL

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.

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

Usual Care

NO INTERVENTION

Usual inpatient care with IV furosemide. Discharge timing determined by treating physician per standard practice.

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.

Also known as: subcutaneous furosemide

Early Discharge with Subcutaneous Furosemide

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

University of Texas Southwestern Medical Center

Dallas, Texas, 75209, United States

Location

Baylor Scott and White Health System

Dallas, Texas, 75246, United States

Location

Related Publications (7)

• Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. No abstract available.

  PMID: 37797885 BACKGROUND

• Bhatnagar R, Fonarow GC, Heidenreich PA, Ziaeian B. Expenditure on Heart Failure in the United States: The Medical Expenditure Panel Survey 2009-2018. JACC Heart Fail. 2022 Aug;10(8):571-580. doi: 10.1016/j.jchf.2022.05.006. Epub 2022 Jul 6.

  PMID: 35902161 BACKGROUND

• Akintoye E, Briasoulis A, Egbe A, Adegbala O, Sheikh M, Singh M, Alliu S, Ahmed A, Asleh R, Kushwaha S, Levine D. Regional Variation in Mortality, Length of Stay, Cost, and Discharge Disposition Among Patients Admitted for Heart Failure in the United States. Am J Cardiol. 2017 Sep 1;120(5):817-824. doi: 10.1016/j.amjcard.2017.05.058. Epub 2017 Jun 15.

  PMID: 28705376 BACKGROUND

• Khan H, Greene SJ, Fonarow GC, Kalogeropoulos AP, Ambrosy AP, Maggioni AP, Zannad F, Konstam MA, Swedberg K, Yancy CW, Gheorghiade M, Butler J; EVEREST Trial Investigators. Length of hospital stay and 30-day readmission following heart failure hospitalization: insights from the EVEREST trial. Eur J Heart Fail. 2015 Oct;17(10):1022-31. doi: 10.1002/ejhf.282. Epub 2015 May 9.

  PMID: 25960401 BACKGROUND

• Sud M, Yu B, Wijeysundera HC, Austin PC, Ko DT, Braga J, Cram P, Spertus JA, Domanski M, Lee DS. Associations Between Short or Long Length of Stay and 30-Day Readmission and Mortality in Hospitalized Patients With Heart Failure. JACC Heart Fail. 2017 Aug;5(8):578-588. doi: 10.1016/j.jchf.2017.03.012. Epub 2017 May 10.

  PMID: 28501521 BACKGROUND

• Reeves GR, Whellan DJ, Patel MJ, O'Connor CM, Duncan P, Eggebeen JD, Morgan TM, Hewston LA, Pastva AM, Kitzman DW. Comparison of Frequency of Frailty and Severely Impaired Physical Function in Patients >/=60 Years Hospitalized With Acute Decompensated Heart Failure Versus Chronic Stable Heart Failure With Reduced and Preserved Left Ventricular Ejection Fraction. Am J Cardiol. 2016 Jun 15;117(12):1953-8. doi: 10.1016/j.amjcard.2016.03.046. Epub 2016 Apr 6.

  PMID: 27156830 BACKGROUND

• Sica DA, Muntendam P, Myers RL, Ter Maaten JM, Sale ME, de Boer RA, Pitt B. Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics of a Newly Buffered Solution. JACC Basic Transl Sci. 2018 Feb 7;3(1):25-34. doi: 10.1016/j.jacbts.2017.10.001. eCollection 2018 Feb.

  PMID: 30062191 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Central Study Contacts

Ambarish Pandey, MD

CONTACT

214-645-2101; ambarish.pandey@utsouthwestern.edu

Neil Keshvani, MD

CONTACT

214-6485198; neil.keshvani@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomization at the cluster level (hospitalist subgroups, academic teaching teams, and cardiology practice groups). Each participating cluster will implement either the early discharge strategy or standard care for initial two-month blocks, followed by a crossover to the alternate strategy.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)