Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
University of Florida
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.
Description
The investigators will conduct an open-label, non-comparative, real-world study to evaluate the effectiveness and feasibility of at-home decongestion treatment using Lasix ONYU in patients with worsening heart failure (WHF). During a clinical visit at the UF Heart Failure Clinic, Emergency Department, or Clinical Decision Unit, the study assess whether a patient meets eligibility criteria for the study.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 or above 2. Previously diagnosed with Congestive Heart Failure (HFpEF or HFrEF) 3. Fluid overload due to worsening HF requiring parenteral diuretic treatment as assessed by at least 2 of the following: 1. BNP \> 200 2. JVP \> 10cmH20 3. Presence of S3 4. LE Edema 5. Weight gain of \> 5lbs in the past 5 days 4. Failed oral uptitration of loop diuretic over the prior 5 days or presented with symptoms too advance to justify additional oral uptitration attempts to resolve congestion symptoms. 5. Expected to require a minimum of three days of parentera…
Interventions
- DrugLasix ONYU
Providing subcutaneous furosemide to eligible patients
Location
- University of FloridaGainesville, Florida