Furoscix in Heart Failure Patients With Diuretic Resistance

NCT ID: NCT05528588

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-02
• Study Completion Date: 2024-07-01

Brief 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).

Detailed 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

≥ 12 BAN-ADHF, Furoscix

Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive Furoscix over 5 hours at 8 mg/mL.

Group Type: EXPERIMENTAL

Furoscix

Intervention Type: COMBINATION_PRODUCT

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).

<= 11 BAN-ADHF, Furoscix

Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive Furoscix over 5 hours at 8 mg/mL.

Group Type: EXPERIMENTAL

Furoscix

Intervention Type: COMBINATION_PRODUCT

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).

≥ 12 BAN-ADHF, control

Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic.

Group Type: ACTIVE_COMPARATOR

Diuretic Therapy

Intervention Type: DRUG

Patients will receive home dose oral furosemide or oral furosemide per standard of care.

<= 11 BAN-ADHF, control

Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive home dose oral diuretic

Group Type: ACTIVE_COMPARATOR

Diuretic Therapy

Intervention Type: DRUG

Patients will receive home dose oral furosemide or oral furosemide per standard of care.

Interventions

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).

Intervention Type: COMBINATION_PRODUCT

Diuretic Therapy

Patients will receive home dose oral furosemide or oral furosemide per standard of care.

Intervention Type: DRUG

Other Intervention Names

subcutaneous furosemide

Eligibility Criteria

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 (eGFR<20) 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

scPharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ambarish Pandey

ASSISTANT PROFESSOR - Internal Medicine (Cardiology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ambarish Pandey, MD, MSCS

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU-2022-0768

Identifier Type: -

Identifier Source: org_study_id