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Nocturnal Blood Pressure and Hypertension - Central and Peripheral 24-h Blood Pressure. (HOSA)

2014年10月8日 更新者：Erling Bjerregaard Pedersen

Nocturnal Blood Pressure in Hypertension, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure

A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of fall in BP during night time) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time BP: chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure is monitored.

Hypothesis:

Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than conventional peripheral monitoring.

In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA.

In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in hormonal balance.

研究概览

地位

未知

条件

详细说明

75 patients with hypertension and chronic kidney disease (CKD I-II) and 75 healthy subjects is examined with both central and peripheral 24 hours blood pressure monitoring, 1 night home polygraphy to determine whether the subject has obstructive sleep apnea (OSA), and if so the degree (apnea hypopnea index, AHI), blood and urine samples to determine levels of urine aquaporine2 (u-AQP2), urine endothelial sodium channel (u-EnaC), plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-aldosterone), plasma vasopressin (p-AVP) and plasma endothelin (p-endothelin).

Hypothesis:

Central 24-h BP monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24-h BP monitoring, because this measurement is painless and does not interfere with activities in the daytime or night-time sleep.

In hypertension, chronic kidney disease and OSA the decease in nocturnal BP is lower than i healthy subjects.

In OSA the decrease in the nocturnal BP is inversely correlated with the severity of OSA.

In OSA is the renal tubular absorption of water and sodium abnormal with increased tubular absorption of water with AQP2 and of sodium by ENAC.

In OSA, there is increased activity of the renin-angiotensin-aldosterone system, increased endothelin in plasma and increased vasopressin in plasma.

研究类型

观察性的

注册 (预期的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Holstebro、丹麦、7500
        • Department of Medical Research and Medicine, Holstebro Regional Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Group 1: 75 patients with hypertension, recruited from another study in the Holstebro Area, contacted by letter.

Group 2: healthy subjects are recruited though posters in public and private companies as well as advertising in local media.

描述

Group 1:

Inclusion Criteria:

  • Chronic kidney disease (CKD stage I and II), estimated glomerule filtration rate (eGFR) 60-90 ml/min/1.73 m2 or eGFR> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
  • Hypertension (BP by ambulatory or home blood pressure> 135/85 mmHg, or consultation blood pressure> 140/90 mmHg).
  • Both men and women
  • 55-70 years
  • A completed consent form

Exclusion Criteria:

  • Lack of desire to participate
  • In the treatment of OSA
  • Malignant disease
  • Abuse of drugs or alcohol
  • Pregnant and breastfeeding
  • Incompensated heart failure
  • Atrial fibrillation
  • Liver disease (Alanine aminotransferase (ALT)> 200)
  • Severe chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second <50% predicted)
  • eGFR <60 ml/min/1.73 m2
  • Blood pressure difference between the right and left arm> 10/10 mmHg

Group 2 - Healthy subjects

Inclusion Criteria:

  • Healthy subjects men and women
  • age 55 - 70 years
  • Body mass index within the normal range, between 18.5 to 25.0 kg/m2

Exclusion Criteria:

  • Arterial hypertension, ambulatory blood pressure> 130 mmHg systolic and / or 80 mmHg diastolic.

    • a history or clinical signs of cardial, pulmonary, hepato, renal, endocrine, cerebral or neoplastic disorders
    • Alcohol abuse, ie. > 14 drinks / week for women and> 21/uge for men
    • Substance abuse
    • Medical treatment apart from oral contraceptives
    • Smoking
    • Pregnancy or breastfeeding
    • Lack of desire to participate
    • Clinically significant, discrepant results of blood or urine sample at inclusion study (B-hemoglobin and B-White blood cell count, p-sodium, p-potassium, p-creatinine, p-ALT, p-bilirubin , p-Alkaline phosphatase, p-cholesterol, p-albumin or b-glucose and urine for hematuria, albuminuria or glucosuria)
    • Clinically significant variations in the electrocardiogram
    • Blood Donation for the past month preceding the day on the first attempt sequence
    • Blood pressure difference between the right and left arm> 10/10 mmHg.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
hypertension
75 patients with hypertension and chronic kidney disease (CKD stage I-II)
healthy subjects
75 healthy subjects

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
decrease in central systolic blood pressure at night
大体时间：< 24 hours
The difference in the decrease in systolic BP at night by peripheral 24-h BP between patients with hypertension and healthy subjects.
< 24 hours

次要结果测量

结果测量
措施说明
大体时间
decrease in central systolic blood pressure at night
大体时间：< 24 hours
The difference in the decrease in systolic BP at night by the central 24-h BP between patients with hypertension and healthy subjects.
< 24 hours
difference i blood pressure levels throughout the day
大体时间：< 24 hours
The difference in systolic blood pressure and diastolic blood pressure throughout the day, in the daytime and in nighttime between peripheral 24-h and central 24-h monitoring in both patients and healthy.
< 24 hours
The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other.
大体时间：< 24 hours
The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other.
< 24 hours
u-AQP2 and u-ENac
大体时间：24 hours
In 24-h urine samples
24 hours
PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin
大体时间：< 1 hour
blood samples
< 1 hour

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Erling Bjerregaard Pedersen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年1月1日

初级完成 (预期的)

2015年12月1日

研究完成 (预期的)

2017年12月1日

研究注册日期

首次提交

2014年3月1日

首先提交符合 QC 标准的

2014年3月1日

首次发布 (估计)

2014年3月5日

研究记录更新

最后更新发布 (估计)

2014年10月9日

上次提交的符合 QC 标准的更新

2014年10月8日

最后验证

2014年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BGH-2-2013
  • M-2013-303-13 (其他标识符：The Regional Committee of health Reseach Ethics)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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