Heart Failure Clinical Trial

Furoscix in Heart Failure Patients With Diuretic Resistance

Summary

This will be a randomized, open-label pilot study of 60 patients with and without diuretic resistance who were recently admitted and discharged for acute decompensated heart failure with and oral furosemide regimen testing whether Furoscix is more effective at achieving post-discharge outpatient diuresis than standard of care. Diuretic resistance will be identified using the BAN-ADHF (BUN, creAtinine, NP-levels, Age, Diabetes and DBP, HF hospitalization, and atrial Fibrillation) score which has been integrated into the electronic health record. The score is integer-based with a score of > 11 indicating diuretic resistance with high likelihood of poor outcomes. The primary outcome is diuretic efficacy as measured by volume of urine produced 8 hours after treatment and urine sodium levels (assessed hourly or per urination episode within 8 hours of treatment).

View Full Description

Full Description

Heart failure is one of the leading causes of hospitalization in the United States, contributing to over 1 million emergency department visits and nearly 1 million hospitalizations for HF annually. The estimated mean cost for HF was $11,552 in 2014, totaling an estimated $11 billion. Thus, strategies to reduce the burden of acute care use for patients with heart failure are necessary. Acute decompensation of heart failure is characterized by volume overload and is primarily treated with intravenous diuretics. However, inefficient and ineffective diuresis both during hospitalization and in the post-discharge environment predispose patients to frequent readmission and a worse prognosis. Importantly, there is heterogeneity in patient response to intravenous diuresis, with an estimated 20-50% of patients having poor response to initial IV diuretic therapy. Patients who are resistant to intravenous diuresis have increased risk of rehospitalization and mortality. Importantly, our group recently derived an integer-based risk score (BAN-ADHF score) to predict patients with low diuretic efficiency.

The investigators will screen eligible patients in the inpatient setting and schedule a research appointment within 14 days after discharge. At the research appointment, patients will be consented and undergo stratified randomization based on BAN-ADHF score (>11 vs. <=11). Within each stratum, patients will be randomized in a 1:1 ratio (intervention: control). The intervention arm (Furoscix over 5 hours at 8mg/mL) will be compared to a usual care group (home oral diuretic dose prescribed by discharge physician). Patients will be monitored for 8 hours in the Clinical Research Unit post-drug administration for clinical safety and to measure clinical response. This study will take place at the Clinical Research Unit in the Aston Building at UT Southwestern Medical Center.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

English speaking patients discharged after ward hospitalization for acute decompensated heart failure with admission NT-proBNP >1000
Able to be screened and enrolled within 14 days of hospitalization
Recent echocardiogram (6 months or less)
Discharged with home diuretic regimen

Exclusion Criteria:

Chronic kidney disease stage 5 (GFR<15) or End Stage Kidney Disease
Systolic blood pressure <100
ICU hospitalization within 3 months
Inotrope use within last 3 months
Home inotropes
Electrolyte abnormalities on discharge
Inadequate data for BAN-ADHF score
Pregnant
Prior heart transplantation or left ventricular assist device
Low-output heart failure
Concurrent use of non-loop diuretic
Advanced liver disease
Severe malnutrition
Skin/Soft tissue condition precluding Furoscix
Inability to collect urine

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT05528588

Recruitment Status:

Active, not recruiting

Sponsor:

University of Texas Southwestern Medical Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

UT Southwestern Medical Center
Dallas Texas, 75235, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT05528588

Recruitment Status:

Active, not recruiting

Sponsor:


University of Texas Southwestern Medical Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.