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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of outpatient intravenous (IV) diuretic therapy for individuals with worsening heart failure. It compares two approaches: receiving treatment in a hospital or at an outpatient clinic. The trial aims to determine which method better alleviates symptoms and improves heart failure management. Individuals struggling with heart failure who require IV diuretics may be suitable candidates, particularly if they visit a Duke outpatient clinic. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance heart failure treatment options.

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.

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

Research has shown that receiving IV diuretic treatment as an outpatient is generally safe for people with worsening heart failure. Studies have found that patients tolerate this treatment well, with a low risk of side effects. For example, one study discovered that outpatient intravenous diuresis, which uses medication to remove extra fluid, significantly reduced the likelihood of patients needing to return to the hospital within 30 days. This finding indicates that the treatment is effective and safe for use outside a hospital. No major reports of serious side effects have emerged, making it a promising option for managing heart failure symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these management strategies for heart failure because they offer new approaches to administering IV diuretics. Unlike traditional treatment, which often requires hospitalization for IV diuretic therapy, one strategy allows patients to receive treatment as outpatients in a clinic setting. This shift could lead to more convenience and less time spent in the hospital. Additionally, comparing these two strategies could provide insights into the most effective and efficient way to manage heart failure, ultimately improving patient outcomes and quality of life.

What evidence suggests that outpatient IV diuretics could be effective for heart failure?

Research shows that administering diuretics through an IV to patients not staying overnight in the hospital can effectively treat heart failure. In this trial, participants may receive outpatient IV diuretics as part of an initial outpatient management strategy. Studies have found that this treatment is safe and can reduce the likelihood of hospital readmission within 30 days. Specifically, one study showed that over 94% of patients avoided hospital admission when they received IV diuretics in a hospital day-care setting. Another study found that increasing the dose of diuretics for patients not staying overnight did not raise the risk of death but did help control heart failure symptoms. These findings support using outpatient IV diuretics as a practical way to manage worsening heart failure. Meanwhile, another group in this trial will follow an initial hospitalization-based management strategy. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephen Greene

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11625734/

Safety and efficacy of outpatient intravenous diuresis in ... OP IV diuresis is a safe and effective treatment for decompensated HF with minimal risk of adverse events. Data demonstrate reduced 30-day readmission, ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2019.12.059

Diuretic Therapy for Patients With Heart Failure For patients on long-term loop diuretic agents, 2.5× their outpatient dose on a mg per mg basis, demonstrated safety and efficacy in the DOSE ...

3. heart.bmj.com heart.bmj.com/content/110/Suppl_3/A181

evaluating the effectiveness of ambulatory intravenous ... Results We analysed the results of 57 patients across 72 treatment episodes. This represents approximately 2.2% of all hospital admissions for heart failure ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1470211824025636

Intravenous diuretic day-care treatment for patients with ... Hospital admission was avoided in 94.1% of cases. The study concluded that iv diuretic treatment given in a hospital day-care setting is safe and effective, and ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.121.008351

Diuretic Changes, Health Care Resource Utilization, and ... Outpatient diuretic dose escalation of any magnitude was associated with heart failure hospitalizations and resource utilization, but not all-cause mortality.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1071916418304883

Efficacy and Safety of an Intravenous Loop Diuretic Dosing ... Little is known about the appropriate use of IV-LD in ambulatory HF patients. We report outcomes of an IV-LD dosing algorithm designed for ambulatory use.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39654948/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0wSL2Z2hcykOsXEGforq7-2uNWUzGo-CDS4ickcWFWr&fc=None&ff=20241212175631&v=2.18.0.post9+e462414

Safety and efficacy of outpatient intravenous diuresis in ... OP IV diuresis is a safe and effective treatment for decompensated HF with minimal risk of adverse events. Data demonstrate reduced 30-day ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04691687?term=LASIX&viewType=Table&rank=5

OUTpatient Intravenous LASix Trial in Reducing ... Single-center, prospective double-blinded randomized control trial to evaluate the the feasibility, efficacy and safety of outpatient IV diuretic therapy in ...