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Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease. (NOSA)

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

Nocturnal Blood Pressure in Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.

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

The aim of this study is to analyse the importance of these three factors on nighttime bloodpressure.

Hypothesis:

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

In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy subjects.

In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the severity of OSA, the severity of kidney disease, and blood pressure during daytime.

研究概览

地位

未知

条件

详细说明

150 patients with chronic kidney disease (CKD III-IV) and 75 healthy subject 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, and if so the degree (AHI), blood- and urine samples to determine levels of u-AQP2 og u-ENaCɣ, PRC, p-AngII, p-Aldosterone, p-Avp og p-Endothelin.

研究类型

观察性的

注册 (预期的)

225

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

18年 至 80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: Patients with chronic kidney disease, CKD stage III-IV. The patients is followed for their kidney disease at Holstebro Regional Hospital, Denmark, Medical clinic, and the are chosen to participate in the study because of this relation.

Group 2: Healthy subjects. They arerecruited through postings on public and private companies as well as advertising in local medier.

描述

Patients, group 1:

Inclusion Criteria:

  • eGFR 15-59 mL/min/1.73 m2 (estimated GFR)
  • 18-80 years
  • males and females

Exclusion Criteria:

  • lack of desire to participate
  • treatment for OSA
  • malignant disease
  • Abuse of drugs or alcohol
  • pregnant and lactating
  • incompensated heart failure
  • atrial fibrillation
  • liver disease (ALAT> 200)
  • Severe chronic obstructive lung disease (forced expiratory volume in 1 second <50% predicted)

Healthy Subjects:

inclusion criteria

  • Healthy volunteers men and women
  • age 40 - 80 years
  • BMI within the normal range, ie. between 18.5 to 25.0 kg/m2

exclusion Criteria

  • Arterial hypertension, ie. 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
  • Daily medicine intake/ 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 (ie B-hemoglobin and B-White blood cell count, p-Sodium, p-Potassium, p-creatinine, p-ALAT, p-bilirubin , p-alkaline phosphatase, p-cholesterol, p-albumin or b-glucose and urine for hematuria, albuminuria or glucosuria)
  • Clinically significant differences in the electrocardiogram
  • Blood Donation for the past month preceding the day on the first attempt sequence.

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
Chronic kidney disease, CKD III+IV
150 patients with Chronic kidney disease, CKD stage III+IV.
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 peripheral systolic blood pressure at night
大体时间：< 24 hours
The difference in the decrease in systolic blood pressure at night by peripheral 24-h BP between patients with chronic kidney disease 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 central 24-h BP between patients with chronic kidney disease and healthy subjects.
< 24 hours
difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime
大体时间：< 24 hours
The difference in systolic blood pressure and diastolic blood pressure throughout the day, during the daytime and during nighttime between measurements with peripheral 24-hour monitoring and central 24 hour monitoring in both patients with chronic kidney disease and healthy subjects.
< 24 hours
The correlation between the decrease in nighttime blood pressure on the one hand and severity of OSA, severity of kidney disease and blood pressure during the daytime on the other.
大体时间：< 24 hours
< 24 hours
U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)
大体时间：24 hours
24 hour urine sample.
24 hours
PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.
大体时间：< 1 hour
< 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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2013年10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10月1日

研究注册日期

首次提交

2013年9月23日

首先提交符合 QC 标准的

2013年9月23日

首次发布 (估计)

2013年9月26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-1-2013
  • M-2013-224-13 (其他标识符：The Regional Committee of Health Research 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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