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

Trial Summary

What is the purpose of this trial?

This trial is testing whether Furoscix, a medication that helps you urinate more, is better for patients after severe heart failure. These patients often struggle with getting rid of excess fluid, which can lead to hospital readmissions. Furoscix works by helping the kidneys remove more salt and water from the body.

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.

What data supports the effectiveness of the drug Furoscix for heart failure?

Furoscix was associated with significant reductions in 30-day heart failure-related healthcare costs compared to patients hospitalized for intravenous diuresis, suggesting it may be an effective and cost-saving option for managing heart failure at home. ^{1 2 3 4 5}

Is Furoscix (furosemide) generally safe for humans?

Furosemide is generally considered a safe diuretic (a medicine that helps remove excess fluid from the body) for a wide range of medical conditions, but it can cause side effects like dehydration and low potassium levels, especially at higher doses. Serious side effects are rare and usually occur in very ill patients. ^{6 7 8 9 10}

How does the drug Furoscix differ from other heart failure treatments?

Furoscix is unique because it allows heart failure patients to receive diuretic treatment at home through a subcutaneous (under the skin) infusion, reducing the need for hospital stays and lowering healthcare costs compared to traditional intravenous diuretic treatments. ^{2 3 5 11 12}

Research Team

Ambarish Pandey, MD, MSCS

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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 speak English and was hospitalized for worsening heart failure with high NT-proBNP levels.

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

You had an echocardiogram within the past 6 months.

Exclusion Criteria

I am severely malnourished.

I have been diagnosed with low-output heart failure.

My condition is advanced liver disease.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Drugs prescribed for chronic heart failure. Current data on their effectiveness]. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Failing diuretics in severe chronic heart failure]. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Reduced heart failure-related healthcare costs with Furoscix versus in-hospital intravenous diuresis in heart failure patients: the FREEDOM-HF study. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Furosemide in acute decompensated heart failure. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Open-label randomized trial of torsemide compared with furosemide therapy for patients with heart failure. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Adverse drug reactions (ADRs) in patients with heart diseases. Comparison between patients without and with heart failure. [2013]

7. Japan pubmed.ncbi.nlm.nih.gov

Comparison of Long-Acting and Short-Acting Loop Diuretics in the Treatment of Heart Failure With Preserved Ejection Fraction. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical toxicity of furosemide in hospitalized patients. A report from the Boston Collaborative Drug Surveillance Program. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Understanding medicines with a propensity to increase the risk of heart failure: Combining existing knowledge with targeted population assessment. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

High furosemide dose has detrimental effects on survival of patients with stable heart failure. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Rational and design of a randomized, double-blind, multicenter trial to evaluate the safety and tolerability of furosemide withdrawal in stable chronic outpatients with heart failure: The ReBIC-1 trial. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Continuous infusion of furosemide in the treatment of patients with congestive heart failure and diuretic resistance. [2022]