Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety of Lasix ONYU Use
研究概览
简要总结
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:
- To evaluate patient factors related to parenteral decongestion at home.
- To evaluate the safety and device operation of Lasix ONYU treatment under circumstances that mimic real-world use.
- To identify opportunities for process improvement before the routine implementation of the new clinical pathway.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •JVP > 10cmH20
- •Presence of S3
- •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.
排除标准
- •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
研究组 & 干预措施
Lasix ONYU
Patients receiving Lasix ONYU
干预措施: Lasix ONYU (Drug)
结局指标
主要结局
Safety of Lasix ONYU Use
时间窗: 30 days
Adverse reactions, acute kidney injury
次要结局
- Hospital Readmission(30 days)