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临床试验/NCT04826250
NCT04826250撤回不适用

The Effect of Timing of Antihypertensive Medication on Diurnal Fluctuations in Blood Pressure Using a Wearable Sensor With Continuous Monitoring

Tel Aviv University2 个研究点 分布在 1 个国家开始时间: 2021年1月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gepner Yftach

Principal Investigator

Tel Aviv University

研究点 (2)

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