NCT06979726 Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
| NCT ID | NCT06979726 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Florida |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-11-20 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 Criteria
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 parenteral diuretic treatment 6. Written informed consent 7. Able and willing to operate Lasix ONYU and comply with study requirements or has a caregiver who can assume these roles. Exclusion Criteria: 1. Age above 80 years 2. Unable or unwilling to provide informed consent. 3. Any medical condition or circumstances that would require further clinical investigation or hospitalization 4. Presence or history of electrolyte abnormalities that may be exacerbated by parenteral loop diuretic treatment 5. Home or current living environment not suitable for outpatient management and diuresis 6. Pregnant or breastfeeding 7. Unable to comply with clinic-required follow up procedure 8. Baseline chronic renal disease with CKD Stage V 9. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06979726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06979726 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06979726 currently recruiting?
Yes, NCT06979726 is actively recruiting participants. Contact the research team at mustafa.ahmed@medicine.ufl.edu for enrollment information.
Where is the NCT06979726 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT06979726 clinical trial?
NCT06979726 is sponsored by University of Florida. The trial plans to enroll 100 participants.
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