Randomized, Double-blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Changes in Left Ventricular Mass Index
研究概览
简要总结
The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure.
This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.
详细描述
We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h ambulatory blood pressure monitoring monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. Matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. All patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm Hg. All analyses were performed central in a core laboratory.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 ys old
- •Male or female with no child bearing potential
- •Seated blood pressure diastolic 90-115 mm Hg
- •Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women
- •Informed consent
排除标准
- •Coronary artery disease, heart failure or other significant cardiac disorder
- •Cerebrovascular accident within the past 6 months
- •A seated systolic blood pressure above 200 mm Hg
- •Significant renal disease, collagen or vascular disease, or gastrointestinal condition
- •Significant allergy or intolerance to study drug
- •Alcohol or drug abuse
- •Uncontrolled diabetes mellitus
研究组 & 干预措施
Irbesartan
Irbesartan per os titrated to 300 mg od, 48 weeks
干预措施: Irbesartan (Drug)
Atenolol
Atenolol per os titrated to 100 mg od, 48 weeks
干预措施: Atenolol (Drug)
结局指标
主要结局
Changes in Left Ventricular Mass Index
时间窗: Baseline and 48 weeks
Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m\^2).
次要结局
- Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System(Baseline to 48 weeks)
- Number of Participants With Serious Adverse Events(Treatment period was baseline to 48 weeks)
- Left Ventricular Diastolic Function Assessed by the E/A Ratio(Baseline to 48 weeks)
- Blood Pressure(Baseline to 48 weeks)
- Effects on Carotid Artery Wall Thickness(Baseline to 48 weeks)
研究者
Thomas Kahan
Professor, Principal investigator and Study Chair
Karolinska Institutet