Furoscix in Heart Failure Patients With Diuretic Resistance

Heart Failure Clinical Trial

— RESISTANCE-HF  

Official title:

Efficacy of Furoscix in Heart Failure Patients With Diuretic Resistance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05528588
• Other study ID #: STU-2022-0768
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a randomized, open-label pilot study of 70 patients with and without diuretic resistance who were recently admitted and discharged for acute decompensated heart failure with and oral diuretic 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 ≥ 12 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).

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 (≥ 12 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 30, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• English-speaking patients discharged after ward hospitalization for acute decompensated heart failure

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Combination Product:
• Furoscix
Study Drug: Furoscix®, (Furosemide Injection), 80 mg/10 mL is a proprietary furosemide formulation that is buffered to a neutral pH to enable subcutaneous administration and contained in a prefilled Crystal Zenith® (CZ) cartridge. Study Device: The Infusor is a compact, ethylene oxide (EtO) sterilized, single-use, electro-mechanical (battery powered, micro-processor controlled), on-body subcutaneous delivery system based on the SmartDose® Gen II 10 mL (West Pharmaceutical Services). The Furoscix Infusor is an investigational drug-device combination product. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).

Drug:
• Diuretic Therapy
Patients will receive home dose oral furosemide or oral furosemide per standard of care.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	scPharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-treatment urine output as measured by cumulative urine output within 1 day.	Post-treatment diuretic efficiency is measured by cumulative urine output in mL per mg of treatment, observed hourly through 8 hours following the administration of study therapy (Furoscix vs. oral furosemide).	1 day
Primary	Post-treatment spot urine sodium levels in 1 day	Post-treatment spot urine sodium levels assessed hourly over 8 hours post-treatment.	1 day
Secondary	Number of participants with post-intervention need for emergency department visit or hospitalization	The count of participants with post-intervention need for emergency department visit or hospitalization for worsening heart failure is assessed.	7 days and 30 days