Trial Outcomes & Findings for Furoscix in Heart Failure Patients With Diuretic Resistance (NCT NCT05528588)

NCT ID: NCT05528588

Last Updated: 2025-07-16

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2025-07-16

Participant Flow

This study enrolled patients who were recently hospitalized with ADHF within 14 days of their discharge who were prescribed diuretic therapy at discharge.

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.

Participant milestones

Measure	≥ 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.	<= 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.	≥ 12 BAN-ADHF, Control Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic.	<= 11 BAN-ADHF, Control Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive home dose oral diuretic
Overall Study STARTED	23	12	23	12
Overall Study COMPLETED	23	12	23	12
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Furoscix in Heart Failure Patients With Diuretic Resistance

Baseline characteristics by cohort

Measure	Oral Furosemide - With Diuretic Resistance n=23 Participants This group received oral furosemide and had diuretic resistance	Oral Furosemide - Without Diuretic Resistance n=12 Participants This group received oral furosemide and was without diuretic resistance	Subcutaneous Furosemide - With Diuretic Resistance n=23 Participants This group received subcutaneous furosemide and had diuretic resistance	Subcutaneous Furosemide - Without Diuretic Resistance n=12 Participants This group received subcutaneous furosemide and was without diuretic resistance	Total n=70 Participants Total of all reporting groups
Age, Continuous	58.1 years STANDARD_DEVIATION 6.9 • n=5 Participants	55.4 years STANDARD_DEVIATION 6.6 • n=7 Participants	57.5 years STANDARD_DEVIATION 9.0 • n=5 Participants	56.0 years STANDARD_DEVIATION 8.4 • n=4 Participants	57.1 years STANDARD_DEVIATION 7.8 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants	8 Participants n=4 Participants	51 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants	8 Participants n=4 Participants	60 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
BAN-ADHF Score	14 units n=5 Participants	6 units n=7 Participants	14 units n=5 Participants	8.5 units n=4 Participants	13 units n=21 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	≥ 12 BAN-ADHF, Furoscix n=23 Participants 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 n=12 Participants 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 n=23 Participants Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic.	<= 11 BAN-ADHF, Control n=12 Participants Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive home dose oral diuretic
Post-treatment Urine Output as Measured by Cumulative Urine Output Within 1 Day.	34.0 mL/mg Interval 29.0 to 38.9	29.8 mL/mg Interval 22.9 to 36.7	22.6 mL/mg Interval 17.6 to 27.6	30.1 mL/mg Interval 23.3 to 37.0

SECONDARY outcome

Timeframe: 1 day

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

Outcome measures

Measure	≥ 12 BAN-ADHF, Furoscix n=23 Participants 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 n=12 Participants 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 n=23 Participants Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic.	<= 11 BAN-ADHF, Control n=12 Participants Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive home dose oral diuretic
Post-treatment Peak Spot Urine Sodium Levels in 1 Day	100 mmol/L Interval 89.0 to 111.0	96 mmol/L Interval 80.0 to 112.0	83 mmol/L Interval 72.0 to 94.0	95 mmol/L Interval 79.0 to 112.0

Adverse Events

Subcutaneous Furosemide

Serious events: 10 serious events

Other events: 6 other events

Deaths: 1 deaths

Oral Furosemide

Serious events: 13 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subcutaneous Furosemide n=35 participants at risk This arm received subcutaneous furosemide (n=35)	Oral Furosemide n=35 participants at risk This group received oral furosemide.
Cardiac disorders Emergency department visit or hospitalization for heart failure	28.6% 10/35 • 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.	37.1% 13/35 • 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.

Other adverse events

Measure	Subcutaneous Furosemide n=35 participants at risk This arm received subcutaneous furosemide (n=35)	Oral Furosemide n=35 participants at risk This group received oral furosemide.
Renal and urinary disorders Increase in creatinine > 0.3 from discharge to end-of-study visit blood test	14.3% 5/35 • 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.	8.6% 3/35 • 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.
Renal and urinary disorders Potassium ≤ 3.0	2.9% 1/35 • 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.	0.00% 0/35 • 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.

Additional Information

Ambarish Pandey, Principal Investigator

UT Southwestern Medical Center

Phone: 2146200286

Email: Ambarish.pandey@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place