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| Name | Class |
|---|---|
| scPharmaceuticals, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ≥ 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. |
|
| <= 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. |
|
| ≥ 12 BAN-ADHF, control | Active Comparator | Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic. |
|
| <= 11 BAN-ADHF, control | Active Comparator | Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive home dose oral diuretic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-treatment Peak Spot Urine Sodium Levels in 1 Day | Post-treatment peak spot urine sodium levels assessed hourly over 8 hours post-treatment. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ambarish Pandey, MD, MSCS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75235 | United States |
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Enrollment was stratified by diuretic resistance based on the BAN-ADHF diuretic efficiency score with score ≥ 12 indicating diuretic resistance. The BAN-ADHF score was calculated using clinical parameters from the index admission.
This study enrolled patients who were recently hospitalized with ADHF within 14 days of their discharge who were prescribed diuretic therapy at discharge.
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| ID | Title | Description |
|---|---|---|
| FG000 | ≥ 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. |
| FG001 | <= 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. |
| FG002 | ≥ 12 BAN-ADHF, Control | Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic. |
| FG003 | <= 11 BAN-ADHF, Control | Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive home dose oral diuretic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Furosemide - With Diuretic Resistance | This group received oral furosemide and had diuretic resistance |
| BG001 | Oral Furosemide - Without Diuretic Resistance | This group received oral furosemide and was without diuretic resistance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Least Squares Mean | 95% Confidence Interval | mL/mg | 1 day |
|
30 days
Safety endpoints included adverse clinical outcomes included 30-day emergency department (ED) visits or heart failure (HF) hospitalizations, and creatinine, estimated glomerular filtration rate, and hypo- or hyperkalaemia at the end of study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subcutaneous Furosemide | This arm received subcutaneous furosemide (n=35) | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency department visit or hospitalization for heart failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in creatinine > 0.3 from discharge to end-of-study visit blood test | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ambarish Pandey, Principal Investigator | UT Southwestern Medical Center | 2146200286 | Ambarish.pandey@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2024 | Apr 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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).
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|
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| Diuretic Therapy | Drug | Patients will receive home dose oral furosemide or oral furosemide per standard of care. |
|
| BG002 | Subcutaneous Furosemide - With Diuretic Resistance | This group received subcutaneous furosemide and had diuretic resistance |
| BG003 | Subcutaneous Furosemide - Without Diuretic Resistance | This group received subcutaneous furosemide and was without diuretic resistance |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| BAN-ADHF Score | The BAN-ADHF score ranges from 0-26 (BAN-ADHF score: blood urea nitrogen, creatinine, natriuretic peptide levels, atrial fibrillation, diastolic blood pressure, hypertension and home diuretic, and heart failure hospitalization). Higher scores indicate greater diuretic resistance risk. | Median | Inter-Quartile Range | units |
|
| OG002 | ≥ 12 BAN-ADHF, Control | Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic. |
| OG003 | <= 11 BAN-ADHF, Control | Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive home dose oral diuretic |
|
|
| Secondary | Post-treatment Peak Spot Urine Sodium Levels in 1 Day | Post-treatment peak spot urine sodium levels assessed hourly over 8 hours post-treatment. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L | 1 day |
|
|
|
| 35 |
| 10 |
| 35 |
| 6 |
| 35 |
| EG001 | Oral Furosemide | This group received oral furosemide. | 0 | 35 | 13 | 35 | 3 | 35 |
| Potassium ≤ 3.0 | Renal and urinary disorders | Systematic Assessment |
|
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