Comparative Study of the Effects of Telmisartan and Nebivolol on 24-h Ambulatory Blood Pressure and Arterial Stiffness in Patients With Arterial Hypertension
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in 24h blood pressure
研究概览
简要总结
Τhe effectiveness of newer angiotensin-II receptor blockers and cardioselective beta-adrenergic blockers in treatment of arterial hypertension and in improvement of arterial stiffness has been established in previous studies among the hypertensive population. The present study is a comparison of the performance of two drugs, telmisartan and nebivolol, in 24h ambulatory blood pressure values and in the degree of arterial stiffness of patients with stage I arterial hypertension.
Measurements will be carried out with the use of 24-h ambulatory blood pressure measurement devices and the method of pulse-wave velocity analysis. The effects of telmisartan and nebivolol are going to be compared for a total time period of 12 months.
The aim of this project is to determine whether the expected decrease in arterial stiffness of subjects with stage I arterial hypertension can be attributed to the blood pressure fall solely, or to other factors as well. These factors are possibly dependent on the action of these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral vasodilatory actions.
The present study is going to be the first comparative test of the anti-hypertensive effects of the two pharmaceutical substances in 12 months' time, and of the elimination of total cardiovascular risk in terms of primary prevention of cardiovascular attacks.
详细描述
INTRODUCTION
We intend to study the effects of telmisartan, a newer angiotensin-II receptor blocker and nebivolol, a cardioselective beta-adrenergic blocker on the 24-h ambulatory blood pressure values of subjects with stage I arterial hypertension in a total time period of 12 months. At the same time, a study of the effects of treatment with the above mentioned antihypertensive drugs on the grade of arterial stiffness of hypertensive subjects will be carried out. The purpose of this project is to determine whether the expected decrease in arterial stiffness of subjects with stage I arterial hypertension can be attributed to the blood pressure fall solely, or to other factors, as well. These factors are possibly dependent on the action of these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral vasodilatory actions.
The objective of the study is to observe and compare, in a time period of 12 months, the performance of two antihypertensives of different drug categories, telmisartan and nebivolol, in treatment of patients with stage I arterial hypertension and in improvement of arterial stiffness. It is an observational study according to the ESH (European Society of Hypertension) guidelines for treatment of patients with arterial hypertension.
METHODS
Study population
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The final selection of the sample of 80 patients diagnosed with stage I arterial hypertension will be based on the ABPM results (24h SBP/DBP ≥ 130/80 mm Hg).
排除标准
- •Patients who present with normal ABPM values at the end of the 3-month period will be excluded from the study. Subjects diagnosed with white-coat hypertension [increased office BP values (SBP/DBP ≥ 140/90 mm Hg) combined with normal ABPM values (24h SBP/DBP < 130/80 mm Hg)] will also be excluded from the study.
- •All subjects with contra-indications for submission of drugs used in the research protocol are going to be excluded from the study. The following categories of patients will not participate in the research: renal failure, hepatic failure, renal artery stenosis, bronchial asthma, vasoconstrictive (Prinzmetal's) angina, hypertrophic cardiomyopathy, aortic valve stenosis, mitral valve stenosis, sinus tachycardia, sinus bradycardia, sick sinus syndrome, Wolff-Parkinson-White syndrome, chronic atrial fibrillation, second and third degree atrioventricular block, right heart failure due to pulmonary hypertension, pheochromocytoma, peripheral artery disease. Pregnant and nursing women will be excluded from the study (history and pregnancy test).
研究组 & 干预措施
NEBIVOLOL
Patients of the group of nebivolol will take 5 mg of nebivolol daily in the morning. At the end of the first month of treatment, patients classified in the normal BP range based on the results of ABPM (24h SBP/DBP < 130/80 mm Hg) will continue on the same medication scheme. Patients still classified in the stage I hypertensive range the nebivolol group will receive 10 mg of nebivolol daily in the morning. At the end of the 6th month patients classified in the normal BP range based on the results of ABPM will continue on the same medication scheme. Patients classified in the stage I hypertensive range 12,5 mg hydrochlorothiazide will be added. The end of the 12-month period from the beginning of the study indicates the completion of the project.
干预措施: NEBIVOLOL (Drug)
TELMISARTAN
Patients of the group of telmisartan will take 40 mg of telmisarta daily in the morning. At the end of the first month of treatment, patients classified in the normal BP range based on the results of ABPM (24h SBP/DBP < 130/80 mm Hg) will continue on the same medication scheme. Patients classified in the stage I hypertensive range will receive 80 mg of telmisartan daily in the morning. The same procedure will be repeated at the end of the 6th month from the beginning of the study. Patients classified in the normal BP range will continue on the same medication scheme. For patients still classified in the stage I hypertensive range12,5 mg of hydrochlorothiazide will be added. The end of the 12-month period from the beginning of the study indicates the completion of the project.
干预措施: TELMISARTAN (Drug)
结局指标
主要结局
Change from baseline in 24h blood pressure
时间窗: 1,6,12 months
Change in 24h BP values in patients with stage I arterial hypertension treated with telmisartan and nebivolol
Change from baseline in arterial stiffness
时间窗: 1,6,12 months
Change in arterial stiffness in patients with stage I arterial hypertension treated with telmisartan and nebivolol
次要结局
未报告次要终点
研究者
Vasilios Kotsis
PROF. MEDICINE
Aristotle University Of Thessaloniki