RecruitingPhase 4NCT06979726

Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure


Sponsor

University of Florida

Enrollment

100 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of the study is to develop, implement, and evaluate a site-specific clinical pathway for at-home treatment of eligible patients presenting to the clinic with worsening heart failure. The secondary objectives are: 1. To evaluate patient factors related to parenteral decongestion at home. 2. To evaluate the safety and device operation of Lasix ONYU treatment under circumstances that mimic real-world use. 3. To identify opportunities for process improvement before the routine implementation of the new clinical pathway.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a furosemide (Lasix) drip given under the skin — rather than through an IV in a hospital — can safely treat fluid overload in people with worsening heart failure in an outpatient setting, potentially avoiding or shortening a hospital stay. **You may be eligible if...** - You are between 18 and 80 years old - You have a prior diagnosis of heart failure (either type) - You are experiencing signs of significant fluid buildup (such as leg swelling, weight gain over 5 pounds in 5 days, or elevated jugular vein pressure) - Increasing oral diuretics has not worked or is not appropriate - You are expected to need at least 3 days of diuretic treatment - You or your caregiver are willing and able to operate the drug delivery device at home **You may NOT be eligible if...** - You are older than 80 - You have severe chronic kidney disease (Stage V) - You have problematic electrolyte levels that could worsen with diuretics - You live in an environment not suitable for outpatient treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLasix ONYU

Providing subcutaneous furosemide to eligible patients


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT06979726


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