Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 32
- 主要终点
- Patient Safety Measured by Serious Adverse Events
研究概览
简要总结
To determine if a strategy of early discharge using a novel subcutaneous delivery system for parenteral furosemide can improve clinical outcomes within 30 days of randomization (days alive and outside the hospital) compared to usual care.
详细描述
SUBQ-HF is a multicenter clinical trial of selected AHF patients with persistent congestion. This study will evaluate a strategy of early discharge (pathway 1) or admission avoidance (pathway 2) with daily SQ furosemide compared to usual care in a population who have objective evidence of persistent congestion requiring ongoing parenteral diuretics. This will be an unblinded, randomized, controlled study of approximately 300 evaluable patients. Eligible patients will be randomized (1:1) to either:
Usual care strategy, during which patients will have continued inpatient treatment and discharge follow-up as per usual standard of care plus a Day 7 phone call and Day 30 study visit.
or
Subcutaneous strategy, in which patients will be discharged home within 24 hours of randomization (pathway 1) or sent home from clinic or ED to receive furosemide with the SQ pump for 1-7 days (based on clinical response) plus a Day 7 and Day 30 visit.
Subcutaneous furosemide/early discharge strategy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subcutaneous Furosemide and sc2wear device
Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.
干预措施: subcutaneous furosemide and sc2wear device (Combination Product)
Usual Care
Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
结局指标
主要结局
Patient Safety Measured by Serious Adverse Events
时间窗: 30 days
measured by serious adverse events
次要结局
- Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia(30 days)
- Medical Costs From Randomization Through 30 Days(30 days)
- Days Alive and Outside the Hospital Through 14 Days(14 days)
- 30 Day Heart Failure Readmission(30 days)
- 30 Day ED Visit for Heart Failure(30 days)
- Death at 30 Days(30 days)
- Change in Breathlessness Through Day 7(7 days)
- Change in Renal Function Using eGFR Baseline to 30 Days(30 days)
- Change in NT Pro BNP From Baseline to 30 Days(30 days)
研究者
Adrian Hernandez
HFN Coordinating Center PI
Duke University