Recruiting

Lasix ONYU

Sponsor:

University of Florida

Code:

NCT06979726

Conditions

Heart Failure

Volume Overload

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lasix ONYU

Study Details

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.

Conditions

Heart Failure

Volume Overload

Study ID

NCT06979726

Start date

Nov 20, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Lasix ONYU

Patients receiving Lasix ONYU

Interventions

Lasix ONYU

Providing subcutaneous furosemide to eligible patients

Primary outcome measure

  • Safety of Lasix ONYU Use [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

More Information

Sponsor

University of Florida

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-08.