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Completed

NCT Number: NCT05528588

Furoscix in Heart Failure Patients With Diuretic Resistance

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: subcutaneous furosemide

Diuretic Therapy

Drug

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

Primary outcomes

  1. Post-treatment Urine Output as Measured by Cumulative Urine Output Within 1 Day.

    Time frame: 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).

Secondary outcomes

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

    Time frame: 1 day

    Post-treatment peak spot urine sodium levels assessed hourly over 8 hours post-treatment.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • scPharmaceuticals, Inc.

Registry information

Official study title

Efficacy of Furoscix in Heart Failure Patients With Diuretic Resistance

Acronym: RESISTANCE-HF

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 6, 2022
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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