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临床试验/NCT00701428
NCT00701428已完成4 期

Phase 4 Study of Losartan in Hypertensive Men and Women With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment

Skaraborg Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
24 h blood pressure (mean blood pressure; mmHg)

研究概览

简要总结

Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup.

详细描述

OSA is a highly prevalent condition in hypertensive patients and the prevalence is even higher in patients with drug-resistant hypertension. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, has an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup. The investigators will include 90 otherwise healthy, untreated hypertensive men and women(age 50-69 yrs, Body-Mass-Index <35 kg/m2; 60 patients with OSA, 30 non-OSA) as described above. Before start of treatment, fasting blood samples will be drawn regarding the neuroendocrine hormones (adrenaline, noradrenaline, plasma renin activity, angiotensin II,aldosterone, pro-BNP) and cardiovascular biomarkers (CRP,interleukines, cytokines). All subjects will start with Losartan 50 mg and 24 h- blood-pressure response and blood sample analysis will be compared between OSA and non-OSA subjects after 6 weeks of treatment. In the second 6-week period, all subjects will continue with Losartan while the half of the OSA group (n=30) will be randomized to CPAP and the other 30 patients will continue with Losartan only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body Mass Index <35 kg/m2
  • Systolic Blood Pressure >=140 mmHg and/or Diastolic Blood Pressure >=95 mmHg
  • No known clinical disease except hypertension
  • No cardiovascular medication
  • Apnea-Hypopnea Index < 5/h (no OSA), or Apnea Hypopnea Index >=15/h (OSA)

排除标准

  • Manifest diabetes, liver- or kidney disease Signs of atrial fibrillation or former myocardial infarction at electrocardiogram

研究组 & 干预措施

1

Active Comparator

Hypertensive Men and Women Without OSA on Losartan (n=30)

干预措施: Losartan (Drug)

2

Active Comparator

Hypertensive Men and Women With OSA on Losartan (n=30)

干预措施: Losartan (Drug)

3

Experimental

Hypertensive Men and Women with OSA on Losartan and CPAP (n=30)

干预措施: Losartan (Drug)

3

Experimental

Hypertensive Men and Women with OSA on Losartan and CPAP (n=30)

干预措施: CPAP (Other)

结局指标

主要结局

24 h blood pressure (mean blood pressure; mmHg)

时间窗: Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively

次要结局

  • Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers(Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively)

研究者

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

Yuksel Peker

MD, PhD, Associate Professor

Skaraborg Hospital

研究点 (1)

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