IV Diuretics for Heart Failure

Overseen By Stephen Greene

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: IV diuretics

Disqualifiers: Heart transplant, Dialysis, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

The purpose of the OUTPATIENT-WHF study is to characterize the effectiveness of outpatient intravenous diuretic therapy as a treatment for worsening heart failure.

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 study team or your doctor.

What data supports the effectiveness of the drug Lasix (furosemide) for heart failure?

Research shows that loop diuretics like furosemide, torsemide, and bumetanide are commonly used for heart failure management. Torsemide was found to have a slightly lower risk of death and hospital readmission compared to furosemide, suggesting some differences in effectiveness among these drugs. ^{1 2 3 4 5}

How is the outpatient IV diuretic treatment for heart failure different from other treatments?

This treatment is unique because it allows patients to receive powerful diuretics (medications that help remove excess fluid) like Lasix and Furosemide through an IV outside of the hospital, either at a clinic or at home. This approach can reduce hospital stays, improve patient satisfaction, and maintain effective treatment for heart failure. ^{2 3 5 6 7}

Research Team

Stephen Greene

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 18 with worsening heart failure who need IV diuretics, as judged by their doctor. They must have completed a health survey and be able to consent. It's not for those with heart devices, severe kidney disease on dialysis, new heart failure diagnosis, pregnancy, high fever at screening or any condition affecting study compliance.

Inclusion Criteria

Able to provide signed informed consent

You have completed the EuroQOL-5 survey.

I was treated with IV diuretics for heart failure at a Duke clinic.

Exclusion Criteria

I prefer a specific treatment location for my heart failure and refuse to be randomly assigned.

Any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol

Pregnant or breast-feeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive outpatient intravenous diuretic therapy or are admitted to the hospital for treatment

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• Initial Hospitalization-based Management Strategy
• Outpatient IV Diuretics

Trial Overview The OUTPATIENT-WHF study tests if giving IV diuretics in an outpatient clinic can effectively treat worsening heart failure compared to the usual initial hospitalization strategy. Patients will either receive treatment in the clinic or be hospitalized.

Participant Groups

Group I: Initial outpatient management strategy, including outpatient IV diuretics in clinic Experimental Treatment 1 Intervention

Group II: Initial hospitalization-based management strategy Experimental Treatment 1 Intervention

Initial Hospitalization-based Management Strategy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lasix for:

• Edema
• Hypertension
• Heart failure

Approved in European Union as Furosemide for:

• Oedema
• Hypertension
• Heart failure

Approved in Canada as Furosemide for:

• Edema
• Hypertension
• Heart failure

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

In a study of over 66,000 heart failure patients, torsemide was associated with the lowest 6-month all-cause mortality risk (13.2%) compared to furosemide (14.5%) and bumetanide (15.6%), suggesting it may be a more effective option for managing heart failure post-hospitalization.

The study also found that torsemide had a lower risk of composite outcomes (HF readmission or all-cause mortality) at 21.4%, compared to 24.7% for furosemide and 24.9% for bumetanide, indicating that the choice of loop diuretic can significantly impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effect of Loop Diuretic Prescription on Mortality and Heart Failure Readmission. Virkud, AV., Chang, PP., Funk, MJ., et al.[2023]

Outpatient diuresis for acute decompensated heart failure (ADHF) in an IV outpatient diuresis (IVOiD) clinic was found to be as effective as inpatient diuresis, with no significant differences in urine output or adverse outcomes among the 36 patients studied.

The IVOiD clinic significantly reduced costs, averaging $839.4 per patient compared to $9895.7 for inpatient care, suggesting that outpatient treatment could be a more economical option for managing ADHF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient versus outpatient intravenous diuresis for the acute exacerbation of chronic heart failure. Halatchev, IG., Wu, WC., Heidenreich, PA., et al.[2023]

A retrospective study of 90 heart failure patients showed that those treated in an ambulatory IV diuretic clinic had a significantly lower risk of rehospitalization or death (HR 0.39) compared to those who underwent short observational hospitalizations.

Patients in the IV diuretic clinic received a median of 3 treatments, suggesting that this outpatient approach may be more effective for managing volume in heart failure patients and preventing future hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory Intravenous Diuretic Clinic Associated with Short-Term Risk Reduction in Mortality and Rehospitalizations in Patients Discharged with Heart Failure. St Amand, A., Taveira, TH., Henthorne, KE., et al.[2021]

In a study of 222 ambulatory patients with congestive heart failure, those treated with torasemide had a significantly lower hospitalization rate (3.6%) compared to those on furosemide (5.4%), suggesting torasemide may be more effective in managing CHF symptoms.

Long-term treatment with torasemide also resulted in fewer hospital days and could potentially halve healthcare costs associated with CHF management, highlighting its clinical and economic advantages over furosemide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term diuretic treatment in heart failure: are there differences between furosemide and torasemide?]. Spannheimer, A., Müller, K., Falkenstein, P., et al.[2018]

A new buffered furosemide formulation allows for effective diuresis in heart failure patients through subcutaneous infusion, achieving nearly complete bioavailability (99.65%) and similar effectiveness to intravenous administration.

This method is well tolerated with no reported skin reactions, making it a promising option for outpatient treatment and potentially reducing the need for emergency or inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics of a Newly Buffered Solution. Sica, DA., Muntendam, P., Myers, RL., et al.[2022]

In a study of 9,653 hospitalized heart failure patients, early initiation of intravenous (IV) diuretics, particularly achieving the maximum dose on the first day, was linked to shorter hospital stays and lower in-hospital mortality rates.

Delaying the time to reach the maximum dose of IV diuretics was associated with worse outcomes, highlighting the importance of timely treatment adjustments for improving patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Intravenous Diuretic Use to Treat Congestion in Patients With Heart Failure - An Observational Study Using a Research Database. Shiraishi, Y., Kurita, Y., Matsukawa, M., et al.[2023]

Outpatient intravenous (IV) diuretic treatment for worsening heart failure (WHF) has been developed in the U.S. over the past decade, offering a promising alternative to traditional hospital-based management, which can be costly and burdensome.

Implementing these outpatient strategies can improve patient satisfaction and quality of life while alleviating pressure on healthcare systems, with practical guidelines provided for clinicians to adopt these new approaches effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical outpatient management of worsening chronic heart failure. Girerd, N., Mewton, N., Tartière, JM., et al.[2022]

References

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

Comparative Effect of Loop Diuretic Prescription on Mortality and Heart Failure Readmission. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Inpatient versus outpatient intravenous diuresis for the acute exacerbation of chronic heart failure. [2023]

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

Ambulatory Intravenous Diuretic Clinic Associated with Short-Term Risk Reduction in Mortality and Rehospitalizations in Patients Discharged with Heart Failure. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Long-term diuretic treatment in heart failure: are there differences between furosemide and torasemide?]. [2018]

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

Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics of a Newly Buffered Solution. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Real-World Intravenous Diuretic Use to Treat Congestion in Patients With Heart Failure - An Observational Study Using a Research Database. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Practical outpatient management of worsening chronic heart failure. [2022]