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| Name | Class |
|---|---|
| SQ Innovation, Inc. | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasix ONYU | Other | Patients receiving Lasix ONYU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasix ONYU | Drug | Providing subcutaneous furosemide to eligible patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Lasix ONYU Use | Adverse reactions, acute kidney injury | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Readmission | 30 day readmission from time of Lasix ONYU administration | 30 days |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustafa M Ahmed, MD | Contact | 352-273-9065 | mustafa.ahmed@medicine.ufl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32608 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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