The Effect of Timing of Antihypertensive Medication on Diurnal Fluctuations in Blood Pressure Using a Wearable Sensor With Continuous Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Nighttime blood pressure
研究概览
简要总结
Minimal or absent of diurnal fluctuation in blood pressure, and specifically conditions in which BP values are elevated during the night compared to daytime (rather than "nighttime dipping"), are associated with higher rates of morbidity and all-cause mortality. However, there is a gap in the scientific literature as to the optimal, individualized, timing of administration of antihypertensive drugs to balance daytime/nighttime fluctuations in BP to reduce the risk for cardiovascular morbidity and all-cause mortality.
To date, the most widely used method for semi-continuous, ambulatory monitoring of BP is a Holter, cuff-based monitor, which is cumbersome to use and therefore results in low patient compliance. Despite various attempts to overcome this problem, practical, patient-friendly methods for continuous BP monitoring throughout the day and night are currently not available.
Thus, the main of this study was to investigate whether there is a differential effect of timing of administration of antihypertensive drugs on diurnal fluctuations in BP using a wearable, cuff-less sensor with continuous monitoring capabilities. It is hypothesized that evening medication will improve BP fluctuations throughout the day (e.g., allow nighttime dipping and prevent morning surges) to a greater extend than morning meditation in people with hypertension.
详细描述
Elevated blood pressure (i.e., hypertension) is a major risk factor for cardiovascular morbidity and all-cause mortality. Medical treatment can significantly improve the prognosis of those with hypertension. It has also been suggested that nighttime medication is more effective in improving mortality and morbidity compared to daytime medication. This hypothesis relates to the fact that lack of a reduction in BP during the night (termed "non-dipping") is associated with a worse prognosis, and therefore nighttime medication can potentially improve the desired diurnal fluctuations in BP and improve health outcomes in those with hypertension to a greater extent than daytime medication. However, whether the timing of drug administration affects the desired diurnal fluctuations in BP remains unknown.
To assess fluctuations in BP throughout the day, and specifically during the night, an ambulatory BP monitoring (ABPM) for 24 hours is required. Research suggests that this method allows classification of hypertension and thus more precise prediction of the patient's cardiovascular risk compared to office-based BP monitoring.
To date, clinician's ability to continuously monitor BP throughout the day has been limited, as the mostly commonly used method of Holter monitoring only allows for BP measurement every 30 min and imposes a significant burden on the patient. The latter limitation affects patients' compliance, and thus clinicians' ability to accurately assess daily BP fluctuations (or lack thereof) that present a major health risk factor.
Thus, the main aim of this study is to use a new wearable, cuff-less technology that that allows continuous ambulatory monitoring of BP to assess whether nighttime medication for hypertension improved diurnal fluctuations in BP to a better extent compared to daytime medication.
Methods:
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension
排除标准
- •hypertensive emergency
- •Those taking more than 3 anti-hypertensive drugs
- •congestive heart failure
- •pregnancy
- •renal failure
研究组 & 干预措施
Hypertensive patients - nighttime medication
Hypertensive patients will be instructed to take their medication in the evening for four consecutive weeks. At the end of this period, participants will switch the timing of medication to the morning for four weeks.
干预措施: Timing of medication (Procedure)
Hypertensive patients - morning medication
Hypertensive patients will be instructed to take their medication in the morning for four consecutive weeks. At the end of this period, participants will switch the timing of medication to the evening for four weeks.
干预措施: Timing of medication (Procedure)
结局指标
主要结局
Nighttime blood pressure
时间窗: At the end of the second four-week intervention
blood pressure measured during the night
morning blood pressure
时间窗: At the end of the second four-week intervention
blood pressure measured during the morning hours
次要结局
- Low and high density lipoprotein cholesterol, total cholesterol, triglycerides(At the end of the second four-week intervention)
- Sodium, potassium(At the end of the second four-week intervention)
- Insulin(At the end of the second four-week intervention)
- Blood Glucose(At the end of the second four-week intervention)
研究者
Gepner Yftach
Principal Investigator
Tel Aviv University
