Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 31
- 主要终点
- Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis
研究概览
简要总结
A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident hemodialysis patients. The study will enroll up to 2,600 subjects. A maximum of 200 sites in the USA will be used for enrollment.
详细描述
Objective:
To study the impact of wearable cardioverter defibrillator (WCD) use on sudden cardiac death in hemodialysis patients.
Study Population:
Participants will be patients beginning hemodialysis (<2 months from initiation) who are ≥ 50 years old.
Intervention:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal disease (ESRD) requiring hemodialysis
- •On hemodialysis for ≤ 2 calendar months or scheduled to begin hemodialysis within 1 calendar month
- •≥50 years of age
- •Documented Ejection Fraction > 35% within the previous calendar year
- •- If the patient has been hospitalized for a myocardial infarction or heart failure decompensation, the Ejection Fraction measurement must have occurred during the last hospitalization or after discharge
排除标准
- •Is receiving or will receive hemodialysis due to acute kidney injury and is not expected to receive subsequent chronic hemodialysis therapy
- •Patient has an active ICD
- •Patient has a unipolar pacemaker
- •Patient has physical or mental conditions preventing him/her from interacting with or wearing a Wearable Cardioverter Defibrillator
- •Patient has a chest circumference at the level of the xiphoid of < 24 inches
- •Patient has a chest circumference at the level of the xiphoid of > 56 inches
- •Patient has an advance directive prohibiting resuscitation
- •Patient has cancer or other terminal disease (excluding ESRD) with expected survival less than 6 months
- •Patient is medically unstable for reasons not specifically related to kidney disease
- •Patient is scheduled for live-donor kidney transplantation within 6 calendar months
- •Patient is unable to consent
结局指标
主要结局
Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis
时间窗: 6 months
This is an intention to treat analysis of SCD, with subjects analyzed by randomization assignment regardless of treatment crossovers or noncompliance. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate.
次要结局
- Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months(2 months)
- Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months(6 months)
- Compliance With Wearable Cardioverter Defibrillator Therapy(6 months)
- Total Mortality(6 months)
- Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis(6 months)
- Clinical Status of Sudden Cardiac Arrest (SCA) Survivors(48 hours after SCA)
- Incidence of Potentially Life Threatening Arrhythmias(6 months)
- Risk of Inappropriate Therapy(6 months)