Furoscix in Heart Failure Patients With Diuretic Resistance

NCT05528588 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STU-2022-0768
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Post-treatment Peak Spot Urine Sodium Levels in 1 Day

  1 day

Study Arms (4)

≥ 12 BAN-ADHF, Furoscix

EXPERIMENTAL

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

Combination Product: Furoscix

<= 11 BAN-ADHF, Furoscix

EXPERIMENTAL

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

Combination Product: Furoscix

≥ 12 BAN-ADHF, control

ACTIVE COMPARATOR

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

Drug: Diuretic Therapy

<= 11 BAN-ADHF, control

ACTIVE COMPARATOR

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

Drug: Diuretic Therapy

Interventions

Furoscix 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).

Also known as: subcutaneous furosemide

<= 11 BAN-ADHF, Furoscix; ≥ 12 BAN-ADHF, Furoscix

Diuretic Therapy DRUG

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

<= 11 BAN-ADHF, control; ≥ 12 BAN-ADHF, control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• scPharmaceuticals, Inc.: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ambarish Pandey, Principal Investigator
• Organization: UT Southwestern Medical Center

Ambarish.pandey@utsouthwestern.edu

2146200286

Study Officials

• Ambarish Pandey, MD, MSCS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR - Internal Medicine (Cardiology)

Model Details: Patients will undergo stratified randomization based on BAN-ADHF score (0-11 vs. ≥ 12). Within each stratum, patients will be randomized in a 1:1 ratio (intervention: control).

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 6, 2022
• Study Start: June 2, 2023
• Primary Completion: April 22, 2024
• Study Completion: July 1, 2024
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)