Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 3
- 主要终点
- Intradialytic Hypotension
研究概览
简要总结
For patients with kidney failure requiring hemodialysis treatment, sometimes the blood pressure will drop too low during dialysis. In an effort to prevent that from occurring, patients are frequently told to skip doses of their blood pressure medications. However, whether this actually prevents blood pressure drops during dialysis, and whether it may cause more uncontrolled high blood pressure is unknown. TAKE-HOLD will study the effect of taking or holding blood pressure medication on blood pressure for patients on hemodialysis.
详细描述
High blood pressure (BP) is a major modifiable risk factor for cardiovascular disease, and upwards of 90% of patients with end- stage renal disease (ESRD) have high BP. Appropriate BP management, therefore, is a fundamental part of patient care in ESRD, yet the question of when best to take antihypertensive medications relative to the hemodialysis treatment session remains unanswered. Many patients on hemodialysis suffer from an abrupt fall in BP during the dialysis session (i.e., intradialytic hypotension [IDH]), a phenomenon that is associated with numerous adverse outcomes. In an attempt to minimize IDH, patients are often told to withhold antihypertensive medications prior to hemodialysis, and current guidelines suggest taking antihypertensive medications at night to minimize IDH. However, there are no data regarding the safety of these antihypertensive medication timing strategies, or whether these strategies are effective in reducing IDH.
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
- •Age ≥ 18 years
- •On in-center thrice weekly hemodialysis
- •Dialysis start time in the morning
- •Taking at least one antihypertensive medication
排除标准
- •Initiation of hemodialysis within previous 90 days
- •Inability to provide informed consent
- •Currently participating in another clinical trial (intervention study)
- •>2 unexcused missed dialysis sessions in the previous 30 days
- •Documented heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%)
- •Cardiovascular event (e.g. myocardial infarction, stroke, heart failure) or procedure (e.g., coronary artery bypass, peripheral arterial bypass grafting, carotid artery procedures, aortic procedures) or hospitalization for unstable angina within the previous 90 days
- •End-stage liver disease
- •Planned kidney transplant within the next 90 days
- •Planned dialysis modality switch (to home hemodialysis, peritoneal dialysis, nocturnal hemodialysis) within the next 90 days
- •Pregnancy, currently trying to become pregnant
- •Active infection requiring antibiotic, antifungal or antiviral therapies
- •Any factors judged by the treatment team to be likely to limit adherence to the interventions
- •Active alcohol or substance abuse within the last 12 months
- •Plans to move outside of the treatment area within in the next 90 days
- •Other medical, psychiatric, or behavioral factors that in the judgement of the study team may interfere with study participation or the ability to follow the intervention protocol
结局指标
主要结局
Intradialytic Hypotension
时间窗: 4-week intervention period
Number of participants with ≥30% of dialysis sessions with symptomatic or asymptomatic IDH.
次要结局
- Poorly controlled pre-dialysis blood pressure(4-week intervention period)
- Dialysis Tolerability(4-week intervention period)
研究者
Tara I-Hsin Chang
Assistant Professor of Medicine (Nephrology)
Stanford University