Furoscix for Heart Failure

(RESISTANCE-HF Trial)

Overseen By Ambarish Pandey, MD, MSCS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Diuretics

Must not be taking: Non-loop diuretics

Disqualifiers: Chronic kidney disease, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Furoscix, a new potential drug, is more effective than standard oral diuretics in helping people with heart failure eliminate excess fluid after hospitalization. It focuses on patients recently discharged for heart failure who are on diuretic treatment. Individuals managing heart failure and sent home with a diuretic plan might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you continue your home diuretic regimen. If you are using non-loop diuretics, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Furoscix is generally safe for people with heart failure. Furoscix, a type of furosemide, is a common water pill that helps the body remove extra fluid, relieving heart failure symptoms. The FDA has already approved Furoscix for treating fluid build-up in some heart failure patients, indicating its safety for this purpose.

However, people whose kidneys have stopped making urine or who have had allergic reactions to furosemide or its ingredients should not use Furoscix. These are important safety considerations.

In studies, researchers carefully monitor patient safety and report any side effects. While risks exist, Furoscix has shown promise for those who do not respond to other water pills. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Furoscix because it offers a new way to manage heart failure, especially for patients with diuretic resistance. Unlike traditional oral furosemide pills, Furoscix is administered subcutaneously, meaning it goes directly under the skin, allowing for faster and potentially more effective relief of fluid overload. This method of delivery can help patients who struggle with absorption issues typical of oral medications, offering a more reliable option for managing their symptoms. By targeting heart failure in this novel way, Furoscix promises quicker symptom relief and improved quality of life for patients who haven't found success with current treatments.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research shows that Furoscix, a form of furosemide administered under the skin, may benefit heart failure patients who don't respond well to regular diuretics. In this trial, some participants will receive Furoscix, while others will receive a standard oral diuretic as a control. Studies have found that Furoscix effectively increases urine output, reducing fluid buildup in the body. In earlier trials, patients using Furoscix produced significant urine within eight hours of treatment. This is important because eliminating extra fluid can relieve symptoms like swelling and shortness of breath. Early research also suggests that Furoscix could safely manage heart failure, with no major safety issues reported. Overall, the evidence supports its potential to help remove excess fluid in heart failure patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Ambarish Pandey, MD, MSCS

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking patients recently hospitalized for acute decompensated heart failure with specific blood markers, who can be screened within two weeks of hospital discharge and have a recent echocardiogram. It's not for those with severe kidney disease, very low blood pressure, recent ICU stay or inotrope use, pregnant women, certain other health conditions or treatments.

Inclusion Criteria

I can join the study within 14 days of being hospitalized.

You had an echocardiogram within the past 6 months.

I have been prescribed diuretics to take at home.

Exclusion Criteria

I am severely malnourished.

I have been diagnosed with low-output heart failure.

My condition is advanced liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive Furoscix or home dose oral diuretic, monitored for 8 hours post-administration

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including emergency department visits or hospitalization

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Furoscix
• Furosemide Pill

Trial Overview The study tests if Furoscix is better at removing excess fluid from the body compared to standard diuretic therapy in heart failure patients. Participants are split into groups by chance to receive either Furoscix or their usual care. The main measure of success is how much urine they produce after treatment.

How Is the Trial Designed?

Group I: ≥ 12 BAN-ADHF, Furoscix Experimental Treatment 1 Intervention

Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive Furoscix over 5 hours at 8 mg/mL.

Group II: <= 11 BAN-ADHF, Furoscix Experimental Treatment 1 Intervention

Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive Furoscix over 5 hours at 8 mg/mL.

Group III: ≥ 12 BAN-ADHF, control Active Control 1 Intervention

Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic.

Group IV: <= 11 BAN-ADHF, control Active Control 1 Intervention

Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive home dose oral diuretic

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

scPharmaceuticals, Inc.

Industry Sponsor

Trials

12

Recruited

410+

Published Research Related to This Trial

In a study of 234 patients with chronic heart failure, those treated with torsemide had significantly lower rates of hospital readmission for heart failure (17% vs. 32% for furosemide) and for all cardiovascular causes (44% vs. 59%).

Patients on torsemide also experienced fewer hospital days for heart failure (106 days vs. 296 days for furosemide) and reported greater improvements in fatigue, suggesting that torsemide may be a more effective diuretic for managing chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label randomized trial of torsemide compared with furosemide therapy for patients with heart failure. Murray, MD., Deer, MM., Ferguson, JA., et al.[2019]

In a study of 17,068 hospitalized patients, 13.9% received furosemide, primarily for congestive heart failure, indicating its common use in managing cardiovascular conditions.

While 10.1% of furosemide recipients experienced adverse reactions, serious life-threatening effects were rare, suggesting that furosemide is generally safe, especially when potassium supplements are used to mitigate hypokalemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical toxicity of furosemide in hospitalized patients. A report from the Boston Collaborative Drug Surveillance Program. Greenblatt, DJ., Duhme, DW., Allen, MD., et al.[2019]

In three patients with chronic heart failure who experienced severe symptoms despite standard treatments, high-dose continuous intravenous administration of loop diuretics provided relief, suggesting a potential solution for diuretic-resistant heart failure.

Proper monitoring and management of hydration status in chronic heart failure patients can enhance their prognosis and quality of life, indicating the importance of individualized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Failing diuretics in severe chronic heart failure]. Dormans, TP., Gerlag, PG., Smits, P.[2007]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39620306/

Diuretic efficiency of a single dose of subcutaneous versus ... Aims: Diuretic resistance (DR) in heart failure (HF) is associated with worse outcomes. Furoscix®, a self-administered subcutaneous (sc) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05528588?tab=results

Furoscix in Heart Failure Patients With Diuretic Resistance Safety endpoints included adverse clinical outcomes included 30-day emergency department (ED) visits or heart failure (HF) hospitalizations, and creatinine, ...

3. secure.medicalletter.org secure.medicalletter.org/TML-article-1668d

In Brief: Furoscix - A Subcutaneous Furosemide Infusor for ... DIURETICS IN HF — Diuretics can reduce fluid retention in patients with HF, but their effect on survival is unclear. · EFFICACY AND SAFETY — ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05528588/furoscix-in-heart-failure-patients-with-diuretic-resistance?activelyRecruiting=false&page=633&id=780&slug=chest-pain

Furoscix in Heart Failure Patients With Diuretic Resistance The primary outcome is diuretic efficacy as measured by volume of urine produced 8 hours after treatment and urine sodium levels (assessed ...

5. 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.

6. furoscix.com furoscix.com/hcp-isi-eng/

FUROSCIX® HCP Important Safety Information FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/88/NCT05528588/Prot_SAP_000.pdf

Furoscix in Heart Failure Patients with Diuretic Resistance Data Safety and Monitoring: Patient safety will be tracked over the study. For any adverse events (AE) that occur during their participation ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/209988s000lbl.pdf

furoscix - accessdata.fda.gov FUROSCIX is indicated for the treatment of congestion due to fluid overload in adult patients with New. York Heart Association (NYHA) Class II and Class III ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11860720/

Diuretic efficiency of a single dose of subcutaneous versus ... Diuretic resistance (DR) in heart failure (HF) is associated with worse outcomes. Furoscix®, a self‐administered subcutaneous (sc) furosemide ...

10. clinicaltrial.be clinicaltrial.be/en/details/14995?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Furoscix in Heart Failure Patients With Diuretic Resistan... Patients who are resistant to intravenous diuresis have increased risk of rehospitalization and mortality. Importantly, our group recently ...