NCT00224549已完成4 期
Management of Resistant Hypertension -Pharmacokinetic Assessment of Different Antihypertensive Regimen -Comparison of Two Treatment Strategies: Increase Sodium Depletion or Combined Blockage of Renin-angiotensin System (RAS)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Mean day-time systolic blood pressure (SBP) at week 12, measured with an average blood pressure measurement (ABPM) device
研究概览
简要总结
The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.
详细描述
Tested hypothesis: For essential resistant hypertension, a new regimen based on intensive RAS blockage is non inferior to the recommended regimen based on intensive sodium depletion.
Primary objective: To demonstrate non-inferiority (i.e difference between the two regimen less than 5 mmHg for the mean day-time SBP at week 12)
- One treatment arm including irbesartan 300 mg, hydrochlorothiazide (HCTZ) 12.5mg, amlodipine 5 mg, ramipril 10mg and bisoprolol 10 mg
- One treatment arm including irbesartan 300 mg, HCTZ 12.5mg, amlodipine 5 mg, spironolactone 25 mg, furosemide 40 mg and amiloride 5 mg.
Secondary objectives:
- To assess clinical and biological safety and efficacy of these regimen
- To evaluate predicted factors of controlled or uncontrolled BP
- To evaluate compliance to treatment
- To compare the cost of the different strategies
- To compare the two strategies in terms of endothelial function and left ventricular diastolic filling
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hypertension
- •Resistant hypertension defined by mean day-time SBP > 135 mmHg and DBP > 85 mmHg (determined with ABPM device) after a standardized 4-week regimen including irbesartan, amlodipine and HCTZ.
排除标准
- •Secondary hypertension
- •Unstable angina, history of stroke or coronary heart disease (coronary by-pass or angioplasty) in the previous 3 months
- •History of cough with ACEi or gynecomastia with antialdosterones
- •Heart failure (New York Heart Association [NYHA] III-IV)
- •Contraindication to beta blockers because of bronchopathy or auriculoventricular block
- •Diabetes mellitus (type 1 or 2) with HbA1C > 8%
- •Renal failure with creatinine clearance < 40ml/min (COCKROFT evaluation)
- •Arm circumference > 42 cm
结局指标
主要结局
Mean day-time systolic blood pressure (SBP) at week 12, measured with an average blood pressure measurement (ABPM) device
时间窗: at week 12
Mean day-time systolic blood pressure (SBP) at week 12, measured with an average blood pressure measurement (ABPM) device
次要结局
- Endothelial function (week 0 and 12)(week 0 and 12)
- Echocardiography (week 0 and 12)(week 0 and 12)
- Biological examinations:(during the study)
- Efficacy: mean day-time diastolic blood pressure (DBP) at week 12, mean 24 hours SBP and DBP at week 12 measured with an ABPM device(at week 12,)
- Safety and tolerability:(during the study)
- During the study BP will be evaluated every 4 weeks by home blood pressure measurement [HBPM] in order to detect hypotension)(every 4 weeks)
- blood and urinary electrolytes with creatinemia at week 0, 4, 8, 10 and 12(at week 0, 4, 8, 10 and 12)
- Other explorations:(during)
- brain natriuretic peptide (BNP), active renin, aldosterone at week 0 and 12(at week 0 and 12)
- Treatment compliance (study drug accounting, N-acetyl-seryl-aspartyl-lysyl-proline [Ac SDKP] for angiotensin converting enzyme inhibitor [ACEi])(during the study)
- Pharmacokinetics of drugs (week 0 and 12)(week 0 and 12)
研究者
研究点 (2)
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