IV Diuretics for Heart Failure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Must be taking: IV diuretics
Disqualifiers: Heart transplant, Dialysis, Pregnancy, others
No Placebo Group
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.
12345How 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.
23567Eligibility 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
I am 18 years old or older.
You have completed the EuroQOL-5 survey.
+1 more
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
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Initial outpatient management strategy, including outpatient IV diuretics in clinicExperimental Treatment1 Intervention
Group II: Initial hospitalization-based management strategyExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
Comparative Effect of Loop Diuretic Prescription on Mortality and Heart Failure Readmission. [2023]Loop diuretics are a standard pharmacologic therapy in heart failure (HF) management. Although furosemide is most frequently used, torsemide and bumetanide are increasingly prescribed in clinical practice, possibly because of superior bioavailability. Few real-world comparative effectiveness studies have examined outcomes across all 3 loop diuretics. The study goal was to compare the effects of loop diuretic prescribing at HF hospitalization discharge on mortality and HF readmission. We identified patients in Medicare claims data initiating furosemide, torsemide, or bumetanide after an index HF hospitalization from 2007 to 2017. We estimated 6-month risks of all-cause mortality and a composite outcome (HF readmission or all-cause mortality) using inverse probability of treatment weighting to adjust for relevant confounders. We identified 62,632 furosemide, 1,720 torsemide, and 2,389 bumetanide initiators. The 6-month adjusted all-cause mortality risk was lowest for torsemide (13.2%), followed by furosemide (14.5%) and bumetanide (15.6%). The 6-month composite outcome risk was 21.4% for torsemide, 24.7% for furosemide, and 24.9% for bumetanide. Compared with furosemide, the 6-month all-cause mortality risk was 1.3% (95% confidence interval [CI]: -3.7, 1.0) lower for torsemide and 1.0% (95% CI: -1.2, 3.2) higher for bumetanide, and the 6-month composite outcome risk was 3.3% (95% CI: -6.3, -0.3) lower for torsemide and 0.2% (95% CI: -2.5, 2.9) higher for bumetanide. In conclusion, the findings suggested that the first prescribed loop diuretic following HF hospitalization is associated with clinically important differences in morbidity in older patients receiving torsemide, bumetanide, or furosemide. These differences were consistent for the effect of all-cause mortality alone, but were not statistically significant.
Inpatient versus outpatient intravenous diuresis for the acute exacerbation of chronic heart failure. [2023]We established an IV outpatient diuresis (IVOiD) clinic and conducted a quality improvement project to evaluate safety, effectiveness and costs associated with outpatient versus inpatient diuresis for patients presenting with acute decompensated heart failure (ADHF) to the emergency department (ED).
Ambulatory Intravenous Diuretic Clinic Associated with Short-Term Risk Reduction in Mortality and Rehospitalizations in Patients Discharged with Heart Failure. [2021]Data on effectiveness of ambulatory intravenous (IV) diuretic clinics for volume management in patients with heart failure to prevent rehospitalization and mortality are limited. Therefore, the primary goal of this research is to evaluate the effectiveness of an out- patient multidisciplinary IV diuretic clinic versus standard observational hospitalizations of less than 48 hours for decompensated heart failure on the time to rehospitalization or death.
[Long-term diuretic treatment in heart failure: are there differences between furosemide and torasemide?]. [2018]Treatment for congestive heart failure (CHF) is an important factor in rising health care costs especially in patients requiring repeated hospitalisations. Diuretics remain the most frequently utilized drugs in symptomatic patients. In this study the long-term outcome under furosemide and torasemide, two loop diuretics with different pharmacokinetic properties, were evaluated during one year in an ambulatory care setting.
Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics of a Newly Buffered Solution. [2022]Parenteral diuretics form the cornerstone of decongestion in heart failure. However, parenteral therapy routinely requires emergency room or inpatient care. A novel buffered furosemide formulation with neutral pH was developed to offer "hospital-strength" diuresis for outpatient use, including self-administration at home. Subcutaneous infusion using a biphasic delivery profile resulted in complete bioavailability (99.65%) and equivalent diuresis when compared with intravenous administration. Subcutaneous administration of buffered furosemide was well tolerated with no evidence of any drug-induced skin reactions. Subcutaneous infusion of buffered furosemide in the outpatient setting or home may help to reduce the burden of heart failure.
Real-World Intravenous Diuretic Use to Treat Congestion in Patients With Heart Failure - An Observational Study Using a Research Database. [2023]Background: Intravenous (IV) diuretics are key in the treatment of acute heart failure, but the time of administration can affect outcomes. Using a medical database, we assessed the real-world usage and clinical impact of IV diuretics after admission. Methods and Results: This observational study included hospitalized patients with heart failure who received IV diuretics. Relationships between IV diuretic use and clinical outcomes (duration of hospitalization, in-hospital mortality, readmission) were evaluated using analysis of variance or logistic regression. Overall, 9,653 patients (51.1% male) were assessed (mean age 80.9 years). Most (89.1%) patients had IV loop diuretic treatment initiated on Day 1 of hospitalization and 68.0% achieved the maximum dose on that day. The median duration of hospitalization was 17.0 days. In-hospital mortality was 9.2%; 13.7% of patients were readmitted within 3 months after discharge. There were prognostic relationships between IV diuretic usage and both duration of hospitalization and in-hospital mortality. On multivariable analysis, the time of maximum dose had the biggest impact on outcomes. Duration of hospitalization was prolonged and in-hospital mortality rates increased when the time of maximum dose was delayed. There was little correlation between IV diuretic use and readmission following discharge. Conclusions: Short-term outcomes (duration of hospitalization, in-hospital mortality) correlated with the time of maximum IV diuretic dose; thus, early initiation and subsequent modification of appropriate congestion treatment is critical for prognostic improvement.
Practical outpatient management of worsening chronic heart failure. [2022]Management of worsening heart failure (WHF) has traditionally been hospital-based, but with the rising burden of heart failure (HF), the pressure on healthcare systems exerted by this disease necessitates a different strategy than long (and costly) hospital stays. A strategy for outpatient intravenous (IV) diuretic treatment of WHF has been developed in certain American centres in the past 10 years, whereas European centres have been mostly favouring 'classic' in-hospital management of WHF. Embracing novel, outpatient approaches for treating WHF could substantially reduce the burden on healthcare systems while improving patient's satisfaction and quality of life. The present article is intended to provide essential knowledge and practical guidelines aimed at helping clinicians implement these new ambulatory approaches using day hospital and/or at-home hospitalization. The topics addressed by our group of HF experts include the pathophysiological background of diuretic therapy, the most suitable profile of WHF that may be managed in an ambulatory setting, the pharmacological protocols that can be used, as well as a detailed description of healthcare structures that can be proposed to deliver these ambulatory care interventions. The practical aspects of day hospital and hospital-at-home IV diuretic administration are specifically emphasized. The algorithm provided along with the practical IV diuretic protocols should assist HF clinicians in implementing this new approach in their local clinical setting.