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临床试验/NCT01056367
NCT01056367已完成不适用

Resistant Hypertension in Patients With Type-II-Diabetes Mellitus: Prevalence, Characterization and Treatment

Svendborg Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Pulse wave velocity

研究概览

简要总结

The risk of cardiovascular disease (CVD) in patients with type-II-diabetes mellitus (type-II-DM)is more than doubled and CVD accounts for 70% of deaths in this group of patients.

Hypertension is a major risk factor for CVD in patients with type-II-DM and a major contributor cardiovascular mortality. Uncontrolled- (UH) and resistant hypertension (RH)are more common in patients with type-II-DM, why further bloodpressure (BP) control is needed.

The prevalence of UH and RH has not been examined in a consecutive Danish outpatient population with type-II-DM.

The purpose of this study is to examine the prevalence of resistant hypertension in patients with type-II-diabetes and to examine the characteristics of patients with resistant hypertension as compared to patients with controlled hypertension with regards to arterial stiffness.

详细描述

The risk of cardiovascular disease (CVD) in patients with type-II- diabetes mellitus (type-II-DM) is more than doubled and CVD accounts for 70% of deaths in this group of patients. Hypertension is a major risk factor for CVD in patients with type-II-DM with a major increase in diabetes-related death as a result. Controlled hypertension as well as uncontrolled- and resistant hypertension is more common in patients with type-II-DM than in the general population and are major contributors to CVD and cardiovascular mortality.

Resistant hypertension is defined as BP above 130 mmHg systolic and / or 80 mmHg diastolic despite treatment with 3 antihypertensive agents or more, of which one should be a diuretic, or controlled BP on four antihypertensive agents or more.

The NHANES study estimated the prevalence of hypertension in patients with type-II-DM to 71% and showed that among those with type-II-DM and hypertension only 31% had controlled BP. It is furthermore estimated that resistant that hypertension is present in up to 30% of a hypertensive population and the ALLHAT trial found that 50% of hypertensives needed treatment with three or more antihypertensive agents.

Type-II-DM promotes both small and large artery disease, whereas hypertension promotes primarily large artery disease. As such type-II-DM and hypertension together may influence the entire vascular system. Type-II-DM is strongly associated with development of heart failure and atherosclerosis and it is therefore important to investigate parameters that reflect arterial stiffness (AS), left ventricular function and degree of atherosclerosis.

AS is an age dependent process, where the arterial wall degenerate and elastic fibers are replaced by collagen fibers. The process is accelerated by cardiac risk factors and increased AS can be regarded as both an individual risk factor and a marker reflecting atherosclerosis.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-80 years, informed consent, hypertension, type-II-diabetes mellitus

排除标准

  • Non-compliance, s-creatinin above 200, AFli

结局指标

主要结局

Pulse wave velocity

时间窗: one year

次要结局

  • Myocardial contractility(One year)
  • Pulse wave analysis(One year)

研究者

发起方
Svendborg Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Trine Koustrup Soender

Medical Doctor

Svendborg Hospital

研究点 (1)

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