Phase 2
N=70
Furoscix in Heart Failure Patients With Diuretic Resistance
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT05528588 ↗Enrolled (actual)
70
Serious AEs
32.9%
Results posted
Jul 2025
Primary outcome: Primary: Post-treatment Urine Output as Measured by Cumulative Urine Output Within 1 Day. — 34.0; 29.8; 22.6; 30.1 mL/mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Furoscix (Combination_product); Diuretic Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-treatment Urine Output as Measured by Cumulative Urine Output Within 1 Day. |
34.0; 29.8; 22.6; 30.1 | — |
| SECONDARY Post-treatment Peak Spot Urine Sodium Levels in 1 Day |
100; 96; 83; 95 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT05528588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.