Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
Recruiting
Phase 4
Interventional Study
Heart Failure
Volume Overload
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- University of Florida · Other
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About This Trial
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 circumstanc…
Trial Locations
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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. L…
Contacts