Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failur… (NCT04593823) | Clinical Trial Compass
CompletedPhase 2
Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
United States63 participantsStarted 2021-05-03
Plain-language summary
This is a multicenter, randomized, open label, controlled study evaluating the effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting.
The study drug, Furoscix (furosemide injection 8 mg/ml), is a furosemide solution buffered to a neutral pH containing 80 mg/10 mL for subcutaneous administration over 5 hours via the Furoscix Infusor.
The study objectives are:
1. To provide pilot data on the effectiveness and safety to inform a pivotal trial.
2. To inform population enrichment strategies
3. To refine pivotal trial endpoints and analytical methods
4. To identify operational challenges of study design
5. To assess patient adherence, competence, and experience
6. To familiarize staff and patients with device application and use
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older.
✓. Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background loop diuretic therapy for at least 4 weeks.
✓. Need for augmented diuresis outside of the acute care setting as determined by the investigator.
✓. On background therapy including daily total furosemide equivalent dose (40-160 mg) of loop diuretic or equivalent.
✓. The subject must have signs of volume expansion, defined as two or more of the following six signs:
✓. jugular venous distention
✓. edema (≥ 1+)
✓. ascites
Exclusion criteria
✕. Suspected high risk clinical instability with outpatient treatment.
✕. Presence of a complicating condition, other than heart failure likely to require hospitalization in next 30 days.
What they're measuring
1
Win Ratio of Composite Endpoint
Timeframe: Day 7, Day 30
2
Number of Cardiovascular Deaths
Timeframe: Baseline, 30 Days
3
Number of Heart Failure Hospitalizations
Timeframe: 30 Days
4
Number of Urgent ED/Clinic Visits for Worsening Heart Failure