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临床试验/NCT03598894
NCT03598894
进行中(未招募)
不适用

Non-dipping Hypertension and the Human Chronobiome

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 150 人2018年7月16日

概览

阶段
不适用
干预措施
Ambulatory blood pressure measurements
疾病 / 适应症
Hypertension
发起方
University of Pennsylvania
入组人数
150
试验地点
1
主要终点
Blood pressure [mmHg]
状态
进行中(未招募)
最后更新
3个月前

概览

简要总结

Hypertension is a common condition with a concomitant burden of stroke, kidney disease and myocardial infarction. Its prevalence in developed societies is increasing as they age, and in less developed countries, as their populations assume aspects of the Western diet and lifestyle. Nocturnal non-dipping hypertension (NDHT) - the failure of blood pressure (BP) to dip at night - is estimated to complicate ~40% of hypertensives and is associated with poor outcomes. Randomized controlled trials have shown that a reduction of daytime systolic blood pressure by as little as 5mmHg on average (towards a target of 140mmHg) translates into a measurable clinical benefit. The peak nocturnal difference may be ~15-20mmHg systolic, illustrating the substantial potential for incremental benefit by adequate blood pressure control across the 24 hour cycle in this population. In this study, the investigators wish (i) to establish through repeated assessment, the stability of the non-dipping phenotype (Phase 1), and (ii) to deeply phenotype non-dippers by using parameters assessing day/night patterns, the chronobiome (Phase 2). To facilitate data collection over the course of the study, the investigators use wearable devices and mobile phone applications.

注册库
clinicaltrials.gov
开始日期
2018年7月16日
结束日期
2028年5月31日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Phase 1: Inclusion Criteria (Stability of the non-dipping phenotype)
  • \>18 years of age,
  • Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements,
  • 24h mean wake SBP \>145mmHg at baseline from 24hr-ABPM readings within the past 12 months,
  • Decline of \<10% between mean day time and night time systolic pressures quantified per 24hr-ABPM within the past 6 months,
  • Own a smartphone.

排除标准

  • (Stability of the non-dipping phenotype)
  • Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation.
  • Shift work, defined as recurring work between 22:00-05:00,
  • History of clinically significant obstructive sleep apnea;
  • Urine creatinine \> 1.5 mg/dl in men or \>1.3 mg/del in women,
  • Significant liver disease (\>3x upper limit of normal),
  • Diabetes mellitus,
  • Transmeridian travel across ≥2 time zones in the month prior to ABP sessions,
  • Planned transmeridian travel across more than ≥2 time zones during the planned study activities;
  • \> 2 drinks of alcohol per day;

研究组 & 干预措施

Control NT

matched healthy normotensives 'NT' (24h mean wake SBP \<120mmHg)

干预措施: Ambulatory blood pressure measurements

Control DHT

matched dipping hypertensives 'DHT' (24h mean wake SBP \>145mmHg and a decline of \>10% between mean day time and night time systolic pressures)

干预措施: Ambulatory blood pressure measurements

Case NDHT

Healthy non-dipping hypertensives 'NDHT' (24h mean wake SBP \>145mmHg at baseline and a decline of \<10% between mean day time and night time systolic pressures)

干预措施: Ambulatory blood pressure measurements

结局指标

主要结局

Blood pressure [mmHg]

时间窗: 24-48 hours

Ambulatory blood pressure measurements (ABPM)

次要结局

  • Dipping status [dimensionless ratio](24-48 hours)

研究点 (1)

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