Antihypertensive Treatment in Masked Hypertension for Target Organ Protection (ANTI-MASK)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)
研究概览
简要总结
The primary purpose of the study is to estimate the target organ protection after 12 months of antihypertensive treatment in masked hypertension patients with at least one kind of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria). Improvement was defined as the relevant parameter back to normal or declined at least 20%.
The secondary objectives include: blood pressure lowering effect, target organ damage parameters improvement, and the incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-70 years old
- •Masked hypertension patients, defined as clinic BP<140/90 mmHg, while 24h ambulatory BP ≥130/80 mmHg and (or) daytime BP ≥135/85 mmHg and (or) nighttime BP ≥120/70 mmHg
- •Combined with at least one kind of target organ damage: left ventricular hypertrophy (Cornell voltage combination ≥2440mm·ms or Sokolow-Lyon index ≥4.0mv for male and 3.5mv for female), large arterial stiffness (brachial-ankle pulse wave velocity ≥1400cm/s) and microalbuminuria (twice random urine microalbuminuria/creatinine ratio ≥2.5mg/mmol for male and 3.5mg/mmol for female).
- •Didn't use any anti-hypertension drugs within 2 weeks
- •Be willing to participate in the trials and able to finish clinic visits
排除标准
- •Under antihypertensive treatment
- •Secondary hypertension
- •Taking other medications that may influence BP
- •Sleep apnea syndrome
- •Diabetes combined with microalbuminuria
- •Renal parenchymal disease, such as chronic nephritis, polycystic kidney
- •Occurrence of coronary heart disease, myocardial infraction or stroke within 6 months
- •Structural heart disease, such as hypertrophic cardiomyopathy, dilated cardiomyopathy
- •Alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) upper the twice of normal range, serum creatinine (Scr)≥2.0mg/dl, plasma hypokalemia≥5.5mmol/L,
- •Patients have contraindications to angiotensin receptor blockers (ARBs)
研究组 & 干预措施
Active treatment
Treatment will be started with allisartan isoproxil 80mg once daily taken in the morning during 8:00-9:00. After 2 months, to achieve the target BP (24h BP<130/80 mmHg, and daytime BP <135/85 mmHg, and nighttime BP <120/70 mmHg), allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan Isoproxil.
干预措施: Allisartan Isoproxil (Drug)
Placebo
Placebo tablets are identical to the active study drugs, with a similar schedule of administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)
时间窗: 1 year
Improvement was defined as the relevant parameters (Cornell voltage combination, Sokolow-Lyon index, microalbuminuria/creatinine ratio, brachial-ankle pulse wave velocity) back to normal or declined at least 20%.
次要结局
- brachial-ankle pulse wave velocity(1 year)
- 24h ambulatory blood pressure(1 year)
- electrocardiogram(1 year)
- incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)(1 year)
- microalbuminuria/creatinine ratio(1 year)
研究者
Yan Li
Professor, Doctor of Medicine, Doctor of Philosophy
Shanghai Institute of Hypertension