RADAR-B: A Phase 2 Multi-center Study to Evaluate the Safety and Tolerability of Using Point-of-Care-Guided Manipulation of Ultrafiltration Rate to Prevent Hemodialysis-Associated Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in duration of clinically significant arrhythmia (CSA) per month
研究概览
简要总结
The purpose of this study is to test the feasibility of trials that change the dialysis ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.
详细描述
Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.
Following ILR implantation, subjects will alternate between weekly periods in which the ultrafiltration rate can be unlimited or in which the ultrafiltration rate is limited to ≤10mL/kg/hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance hemodialysis therapy for end-stage renal disease
- •Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
- •>30 days since dialysis initiation
- •Ability to provide informed consent
- •Interdialytic weight gain necessitating an UF rate of ≥13mL/kg/hour of dialysis to achieve the target post-dialysis weight in at least half of the dialysis sessions (≥6 sessions) in the month prior to enrollment
排除标准
- •Expected survival <6 months-to allow trial completion
- •Renal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
- •Prisoners or cognitive disability preventing informed consent
- •Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months
- •Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
- •Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
- •Existing pacemaker, implantable monitor or defibrillator which precludes device placement
- •Chronic, persistent AF (defined as the presence of persistent AF on all available EKGs at time of recent screening)
结局指标
主要结局
Change in duration of clinically significant arrhythmia (CSA) per month
时间窗: 4 months
The total monthly duration of CSA (in minutes) will be utilized as the primary efficacy endpoint in comparing this pair of interventions (aggressive vs. conservative UF). In the event of incomplete follow-up, CSA duration will be indexed to follow-up time. CSA will be defined on the basis of arrhythmias likely to lead to sudden cardiac arrest (SCA) or serious morbidity and mortality and will include AF, asystole ≥3 seconds, bradycardia ≤40 beats per minute lasting ≥6 seconds, and sustained VT ≥130 beats per minute lasting ≥30 seconds. CSA's will be adjudicated by study electrophysiologists.
Adherence with Proposed Interventions
时间窗: 2 years
Adherence will be assessed as the percent of sessions in which the mandated UFR is delivered.
Incidence of unscheduled hemodialysis or hospitalization for volume overload
时间窗: 4 months
The occurrence of unscheduled hemodialysis or ultrafiltration sessions needed to treat volume overload will be measured to assess the impact of the UFR intervention on the adequacy of volume removal.
次要结局
- Comparison of pre- and post-correction adherence(2 years)
- Association of individual interventions with atrial fibrillation (AF)(4 months)
- Association of individual interventions on potentially lethal arrhythmia(4 months)
- The occurrence of clinically significant arrhythmias requiring intervention(4 months)
- All-cause mortality(2 years)
- Hospitalization(2 years)
- Proportion of screened patients enrolled(2 years)
- Cardiovascular mortality(2 years)