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

ConditionsHeart FailureAcute Decompensated 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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Early Discharge with Subcutaneous FurosemideExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
30-day

Secondary outcomes

1

Change in Quality of Life

Longitudinal analysis of Kansas City Cardiomyopathy Overall Summary Scores

Time frame
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.
2

Change in N-terminal pro B-type natriuretic peptide

Longitudinal analysis of N-terminal pro B-type natriuretic peptide (NT-proBNP) levels

Time frame
Baseline, 14-day, and 30-day
3

Time-to-event for mortality and readmission

Time-to-event analyses for mortality and readmission outcomes

Time frame
30-day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: