Comparison of the Efficacy of 24 Hour BP Control of Azelnidipine, Amlodipine and Cilnidipine in Mild to Moderate Essential Hypertension – a Prospective Multi-centric Parallel Arm Real-world Study (AMCILAZ-EH Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 8
- 主要终点
- Change in Awake, 24 hour and Asleep Blood Pressure (SBP/DBP) between baseline and 8 weeks for the three arms using ABPM
研究概览
简要总结
Calcium channel blockers are the most commonly used antihypertensive agents. The three approved agents in use commonly are amlodipine, Cilnidipine and Azelnidipine. There is no head to head multicenter comparative study of these agents
This is a parallel arm open labelled observational multicenter study of mild to moderate hypertension. Both newly diagnosed and known cases of hypertension are included.
The objective is to compare primarily the BP lowering quantified by Ambulatory Blood Pressure Monitoring response of these three aforementioned drugs over a period of 8 weeks(+/-one week)
Apart from previous use of these drugs, important confounders like irregular pulse, night shift have been excluded.
Secondary outcomes are change in urinary albumin creatinine ratio over three months, change in the dipping pattern and changes in LA strain in a subgroup of patients with left ventricular hypertrophy. Adverse outcomes to drugs are also noted.
The expected conclusion will show the comparative efficacy and safety of these three calcium channel blockers in Indian patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Known cases of Essential hypertension ie.
- •â‰¥ 140/90 mm Hg as Office based recording that are naïve to beta-blocker, and CCB OR Known cases of Essential hypertension ie.
- •â‰¥ 140/90 mm Hg as Office based recording along with either T2DM, LVD and/or CKD that are naïve to beta-blocker, and CCB.
排除标准
- •known allergy to any of the Calcium channel blockers, history of active thyroid disease, CKD stage 3 or more, eGFR less than 30 ml/min/sq.m, Office BP more than 180/110 mm Hg, Secondary hypertension, type 1 diabetes mellitus, active liver disease, pregnant women, women planning pregnancy or lactating mother, person working in night shift, more than moderate valvular heart disease, pericardial disease, irregular rhythm like atrial fibrillation, unstable heart disease or heart failure.
结局指标
主要结局
Change in Awake, 24 hour and Asleep Blood Pressure (SBP/DBP) between baseline and 8 weeks for the three arms using ABPM
时间窗: 8 weeks for the three arms using ABPM | Change in office based Blood Pressure (SBP/DBP) between baseline and 4th, 8th week and 12th week for all the three arms
Change in office based Blood Pressure (SBP/DBP) between baseline and 4th, 8th week and 12th week for all the three arms
时间窗: 8 weeks for the three arms using ABPM | Change in office based Blood Pressure (SBP/DBP) between baseline and 4th, 8th week and 12th week for all the three arms
次要结局
- change in dipping pattern between groups(8 weeks)
- Proportions of patients achieving awake BP control of 135/85 mm Hg by ambulatory BP(8 weeks)
- proportions of patients achieving treatment induced adverse effects(12 weeks)
- study the change in heart rate by ambulatory BP in the three groups(8 weeks)
- Changes in left ventricular (LV) mass index, LV Hypertrophy, LV global longitudinal strain, left atrial strain(12 weeks)
- changes in microalbuminuria/ albumin creatinine ratio between the three groups(12 weeks)
研究者
DPrabhakar
Ashwin Clinic