NCT05528588: RESISTANCE-HF

Furoscix in Heart Failure Patients With Diuretic Resistance

Completed Phase 2 Results posted Last updated 16 July 2025

What this trial tests

Phase 2 trial testing Furoscix in Heart Failure in 70 participants. Completed in 1 July 2024.

Timeline

2 June 2023

Primary endpoint
22 April 2024

1 July 2024

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	2 June 2023
Primary completion	22 April 2024
Estimated completion	1 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Furoscix
• Diuretic Therapy — full drug profile →

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 80, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
≥ 12 BAN-ADHF, Furoscix	34.0	29.0 – 38.9
<= 11 BAN-ADHF, Furoscix	29.8	22.9 – 36.7
≥ 12 BAN-ADHF, Control	22.6	17.6 – 27.6
<= 11 BAN-ADHF, Control	30.1	23.3 – 37.0

Post-treatment Peak Spot Urine Sodium Levels in 1 Day Secondary · 1 day

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

Group	Value	95% CI
≥ 12 BAN-ADHF, Furoscix	100	89 – 111
<= 11 BAN-ADHF, Furoscix	96	80 – 112
≥ 12 BAN-ADHF, Control	83	72 – 94
<= 11 BAN-ADHF, Control	95	79 – 112

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Subcutaneous Furosemide

Serious: 10/35 (29%)

Deaths: 1/35

Oral Furosemide

Serious: 13/35 (37%)

Deaths: 0/35

Serious adverse events (1 terms)

Reaction	System	Subcutaneous Furosemide	Oral Furosemide
Emergency department visit or hospitalization for heart failure	Cardiac disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Subcutaneous Furosemide	Oral Furosemide
Increase in creatinine > 0.3 from discharge to end-of-study visit blood test	Renal and urinary disorders	—	—
Potassium ≤ 3.0	Renal and urinary disorders	—	—

Most-reported serious reactions: Emergency department visit or hospitalization for heart failure.

Data from ClinicalTrials.gov NCT05528588 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Diuretic efficiency of a single dose of subcutaneous versus oral furosemide after heart failure hospitalization across diuretic resistance strata: A pilot randomized controlled trial.
   Keshvani N, Rizvi S, Segar MW, Miller JW, et al · · 2025 · cited 6× · PMID 39620306 · DOI 10.1002/ejhf.3537