Heart FailurePhase 2RESISTANCE-HFNCT05528588
Furoscix in Heart Failure Patients With Diuretic Resistance
A Phase 2 study testing Furoscix and Diuretic Therapy in people with Heart Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Furoscix and Diuretic Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2023to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of 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).
Read the 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
- Being tested
- Furoscix, Diuretic Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FuroscixCombination product
Also called subcutaneous furosemide
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).
Diuretic TherapyDrug
Patients will receive home dose oral furosemide or oral furosemide per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| ≥ 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: Diuretic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (1)
Post-treatment Peak Spot Urine Sodium Levels in 1 Day
Post-treatment peak spot urine sodium levels assessed hourly over 8 hours post-treatment.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start2 Jun 2023
- Primary completion22 Apr 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- scPharmaceuticals, Inc.
- Responsible party
- Principal investigator, Ambarish Pandey, University of Texas Southwestern Medical Center
- Investigators
- Ambarish Pandey, MD, MSCS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528588
- Sponsor's protocol ID
- STU-2022-0768
- Acronym
- RESISTANCE-HF
- Status last verified
- Jun 2025
- First submitted
- 31 Aug 2022
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Furoscix in Heart Failure Patients With Diuretic Resistance
- ClinicalTrials.gov ID
- NCT05528588
- Acronym / sponsor ID
- RESISTANCE-HF / STU-2022-0768
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- scPharmaceuticals, Inc.
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ≥ 12 BAN-ADHF, Furoscix | Experimental | Combination Product: FuroscixPatients 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 | Combination Product: FuroscixPatients 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 | Drug: Diuretic TherapyPatients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic. |
| <= 11 BAN-ADHF, control | Active comparator | Drug: Diuretic TherapyPatients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive home dose oral diuretic |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FuroscixAlso: subcutaneous furosemideStudy 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). | Combination product | <= 11 BAN-ADHF, Furoscix, ≥ 12 BAN-ADHF, Furoscix |
| Diuretic TherapyPatients will receive home dose oral furosemide or oral furosemide per standard of care. | Drug | <= 11 BAN-ADHF, control, ≥ 12 BAN-ADHF, control |
Primary outcome
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).
1 secondary outcome
Post-treatment Peak Spot Urine Sodium Levels in 1 Day
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ambarish Pandey, MD, MSCS principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furoscix and Diuretic Therapy in people with Heart Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment Urine Output as Measured by Cumulative Urine Output Within 1 Day. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.