Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 13
- 主要终点
- Change in mean home systolic BP for the group treated initially with monotherapy compared to the group treated initially with combination therapy.
研究概览
简要总结
To test whether the current custom of initiating treatment for hypertension with a single drug is less effective in the short-term than initial combination therapy, and results in the eventual need for comparatively more antihypertensive drug therapy.
详细描述
To determine if patients randomised to more aggressive (combination therapy) treatment for the initial treatment of hypertension have better blood pressure control compared to those randomised to less aggressive (monotherapy) treatment despite subsequent add-on treatment being similar in each group. This will test the hypothesis that monotherapy patients 'never catch up' with combination therapy patients.
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To determine if this 'never catch-up' phenomenon of improved BP control persists for at least one year.
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To understand the underlying mechanism of improved BP control; specifically:
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To determine if it is due to haemodynamic compensation, such as increased sodium retention and volume expansion.
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To determine if it is due to increased peripheral resistance.
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To understand the predictors of BP control i.e. age, baseline renin status, sodium status and plasma volume.
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To validate the National Institute for Clinical Excellence / British Hypertension Society joint guideline ACD algorithm by comparing BP control in the monotherapy crossover arm of phase 1 and to correlate this with age (≤ 55 or > 55y), and baseline characteristics such as renin.
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To determine the safety and tolerability of a strategy of prescribing combination therapy as the initial step versus monotherapy as the initial step.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combination Therapy
Patients treated with combination therapy of Hydrochlorthiazide plus Losartan. Losartan will be force-titrated from 50 to 100mg, Hydrochlorothiazide will be force-titrated from 12.5mg to 25mg
干预措施: Losartan and hydrochlorothiazide (Drug)
Monotherapy
Initial monotherapy Hydrochlorothiazide 12.5mg -25mg Crossed over with Losartan 50 -100mg at 8 weeks
干预措施: Hydrochlorothiazide switched over with Losartan at 8 weeks (Drug)
结局指标
主要结局
Change in mean home systolic BP for the group treated initially with monotherapy compared to the group treated initially with combination therapy.
时间窗: 1 year
次要结局
- A comparison the proportion of patients who drop out of the trial at any stage after randomisation or who require further antihypertensive treatment(1 year)
研究者
Morris Brown
Prof Morris Brown
University of Cambridge