NCT05704595撤回不适用
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Days alive and out of hospital
研究概览
简要总结
The purpose of the OUTPATIENT-WHF study is to characterize the effectiveness of outpatient intravenous diuretic therapy as a treatment for worsening heart failure.
详细描述
The purpose of this study is to determine whether treating certain patients with worsening heart failure as an outpatient with intravenous and oral medications can work just as well as treating patients in the hospital.
Participants who enter into the study and meet eligibility criteria will be randomly chosen to either get intravenous diuretic like Lasix in the clinic and get outpatient care, versus directly admitted to the hospital to receive intravenous diuretic and normal hospital care.
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
- •≥18 years of age
- •Presentation to a Duke outpatient clinic with heart failure requiring IV diuretics, as per clinician judgement
- •Able to provide signed informed consent
- •Successful completion of EuroQOL-5 dimensions survey
排除标准
- •Managing clinician without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.
- •Patient without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.
- •History of left ventricular assist device or heart transplantation
- •End-stage kidney disease requiring chronic dialysis therapy
- •New diagnosis of heart failure
- •Pregnant or breast-feeding
- •Fever >101.0 degrees Fahrenheit at screening
- •Any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol
结局指标
主要结局
Days alive and out of hospital
时间窗: 30 days
次要结局
- Days alive and out of hospital(90 days)
- Total emergency department visits(90 days)
- Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index(90 days)
- Death(90 days)
- Total hospitalizations(90 days)
- Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)(90 days)
研究者
研究点 (2)
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