BridgeMD
New treatment option for Heart Failure
Official title Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
ClinicalTrials.gov ID: NCT06979726
What this study is testing
What is Lasix ONYU?
Lasix ONYU is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join 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
See the full eligibility 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:
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.