Subcutaneous Furosemide for Heart Failure

Not yet recruiting at 1 trial location

Overseen By Neil Keshvani, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Cognitive impairment, Pregnancy, End-stage HF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 2 months per strategy (crossover design)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating heart failure, a condition where the heart doesn't pump effectively. The researchers aim to determine if patients can safely leave the hospital sooner by using a subcutaneous (under the skin) form of the drug furosemide (a diuretic) at home, instead of the usual inpatient care with intravenous (IV) furosemide. The main goal is to assess whether this home treatment helps people avoid hospital readmission for at least 30 days. Suitable participants have been admitted to the hospital for heart failure within the last 48 hours and can manage the treatment at home. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering patients a chance to contribute to a potentially groundbreaking therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that subcutaneous furosemide is likely to be safe for humans?

Studies have shown that administering furosemide under the skin is generally safe for people with heart failure. Research involving 687 patients found it helps manage symptoms without serious safety concerns. Another review found that although some patients experienced serious side effects, these were not caused by the furosemide treatment itself. This suggests that furosemide given this way is well-tolerated. It is important to note that this form of the drug is being tested to determine if it can help patients leave the hospital earlier, potentially offering more convenience. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment for heart failure, which typically involves intravenous (IV) furosemide administered in hospitals, subcutaneous furosemide offers a novel delivery method. This treatment is unique because it allows patients to receive furosemide through a subcutaneous infusion at home, potentially enabling earlier discharge from the hospital. Researchers are excited about this approach as it could improve patients' quality of life by reducing hospital stays and making management of heart failure more convenient and accessible.

What evidence suggests that subcutaneous furosemide might be an effective treatment for heart failure?

In this trial, participants will join one of two groups. One group will receive early discharge with subcutaneous furosemide, administered at home using a SQIN-Infusor device. Research has shown that administering furosemide under the skin can effectively manage symptoms in people with heart failure. One study found that patients receiving furosemide this way had fewer hospital visits compared to those receiving it intravenously, with hospitalization rates of 64.8% for subcutaneous furosemide versus 84.5% for the intravenous method. Another review suggests that using furosemide under the skin at home could reduce the need for hospital stays, potentially saving money. These findings indicate that this method could be a promising alternative for managing heart failure symptoms outside the hospital. Meanwhile, the other group in this trial will receive usual inpatient care with IV furosemide, with discharge timing determined by the treating physician per standard practice. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for patients within 48 hours of being admitted to the hospital or emergency department for heart failure, who are planning on admission or short-stay hospitalization. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am 18 years old or older.

I or my caregiver can use a needle-free injection device.

I was admitted or observed in the hospital for heart failure within the last 48 hours.

Exclusion Criteria

I am able to understand and give consent for my treatment.

Geographic barriers to follow-up

My kidney function is very low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either early discharge with subcutaneous furosemide or standard inpatient care with IV furosemide

2 months per strategy (crossover design)

Inpatient stay followed by home visits for subcutaneous furosemide group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including days alive and out of the hospital

30 days

Retrospective review of electronic health records

Long-term Follow-up

Longitudinal analysis of NT-proBNP levels and quality of life scores

30 days

Baseline, 14-day, and 30-day assessments

What Are the Treatments Tested in This Trial?

Interventions

• Furosemide

Trial Overview The study tests if early discharge with subcutaneous furosemide (Lasix® ONYU) using an SQIN-Infusor is as effective as standard inpatient care for heart failure. It's a non-inferiority trial where practice groups will alternate between the two treatments over two-month periods.

How Is the Trial Designed?

Group I: Early Discharge with Subcutaneous Furosemide Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11538160/

The Role of Subcutaneous Furosemide in Heart Failure ... This study analyzed 687 patients from 20 studies. The results demonstrate that SC furosemide can effectively manage symptomatic congestion in HF ...

2. academic.oup.com academic.oup.com/ehjcvp/article/11/1/94/7888904

Subcutaneous furosemide in heart failure: a systematic review Serious AEs were reported in 35% of subcutaneous and 24% of usual care groups, none of which were deemed related to treatment with furosemide.

3. jacc.org jacc.org/doi/10.1016/S0735-1097%2825%2901991-6

COMPARATIVE EFFECTIVENESS OF SUBCUTANEOUS ... The SC furosemide group had significantly lower hospitalization rates compared to the IV furosemide group (64.8% vs. 84.5%, p=0.007). Secondary composite ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07018297

Study Details | NCT07018297 | Early Discharge With ... This trial aims to address this knowledge gap through a cluster-randomized crossover study comparing early discharge with subcutaneous furosemide to standard ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2474870622018668

Review Article From Oral to Subcutaneous Furosemide These preliminary results suggest that Furoscix, when used in the home setting, leads to significant cost savings by reducing the need for hospital admissions.

6. jacc.org jacc.org/doi/10.1016/j.jchf.2024.07.015

A Pilot Study (AT HOME-HF) | JACC: Heart Failure This pilot study assessed outcomes of a novel subcutaneous (SC) furosemide formulation compared to usual care in outpatients with worsening congestion.