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

NCT06979726 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB202500547
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate patient factors related to parenteral decongestion at home.
2. 2.To evaluate the safety and device operation of Lasix ONYU treatment under circumstances that mimic real-world use.
3. 3.To identify opportunities for process improvement before the routine implementation of the new clinical pathway.

Conditions

Heart Failure; Volume Overload

Outcome Measures

Primary Outcomes (1)

• Safety of Lasix ONYU Use

  Adverse reactions, acute kidney injury

  30 days

Secondary Outcomes (1)

• Hospital Readmission

  30 days

Study Arms (1)

Lasix ONYU

OTHER

Patients receiving Lasix ONYU

Drug: Lasix ONYU

Interventions

Lasix ONYU DRUG

Providing subcutaneous furosemide to eligible patients

Lasix ONYU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above
• Previously diagnosed with Congestive Heart Failure (HFpEF or HFrEF)
• Fluid overload due to worsening HF requiring parenteral diuretic treatment as assessed by at least 2 of the following:
• BNP \> 200
• JVP \> 10cmH20
• Presence of S3
• LE Edema
• Weight gain of \> 5lbs in the past 5 days
• 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.
• Expected to require a minimum of three days of parenteral diuretic treatment
• Written informed consent
• Able and willing to operate Lasix ONYU and comply with study requirements or has a caregiver who can assume these roles.

You may not qualify if:

• Age above 80 years
• Unable or unwilling to provide informed consent.
• Any medical condition or circumstances that would require further clinical investigation or hospitalization
• Presence or history of electrolyte abnormalities that may be exacerbated by parenteral loop diuretic treatment
• Home or current living environment not suitable for outpatient management and diuresis
• Pregnant or breastfeeding
• Unable to comply with clinic-required follow up procedure
• Baseline chronic renal disease with CKD Stage V
• Any surgical or medical condition which, in the opinion of the investigator, may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data

Sponsors & Collaborators

• University of Florida: lead
• SQ Innovation, Inc.: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Edema

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mustafa M Ahmed, MD

CONTACT

352-273-9065; mustafa.ahmed@medicine.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: November 20, 2025
• Primary Completion: March 31, 2026
• Study Completion: May 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-05

Locations

US (1)