MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,240
- 试验地点
- 2
- 主要终点
- changes in LVMI (co-primary endpoint)
研究概览
简要总结
MASTER study is a 4-year prospective, randomized, open-label, blinded-endpoint study (PROBE) comparing 2 management strategies 1) office BP as a guide to treatment, or 2) 24-hour ABP as a guide to treatment. Study objectives are to investigate whether a management strategy based on out-of-office BP (Ambulatory BP monitoring) versus a management strategy based on office BP measurements is associated with differences in outcome, including cardiovascular and renal intermediate end points at one year; cardiovascular events at 4 years and changes in a number of blood pressure-related variables throughout the study. Patients will be followed-up during the first year focusing on changes in left ventricular mass index (LVMI, co-primary endpoint) and Urinary albumin excretion (UAE, albumin/creatinine ratio, co-primary end-point), and during the whole 48 month period for both changes in LVMI and UAE and events including all-cause mortality, CV morbidity and mortality, cerebral morbidity and mortality.A total of 1240 subjects will be recruited by 30 centers, taking into account a dropout rate of 15% (620 subjects per randomization arm).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects
- •Age 35-80 years
- •Masked uncontrolled (in treatment) hypertension: office BP <140/90 mmHg, and one or more of the following situations:
- •Ambulatory daytime BP >135/85 mmHg
- •Ambulatory night-time ABP > 120/70 mmHg
- •Ambulatory 24h ABP >130/80 mmHg
- •eGFR ≥45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009)
排除标准
- •eGFR <45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009), and in particular severe chronic renal failure defined as serum creatinine > 250 umol/l;
- •Patients in unstable clinical conditions;
- •Known secondary hypertension;
- •Orthostatic hypotension (SBP fall > 20 mmHg on standing);
- •Dementia (clinical diagnosis);
- •Hepatic disease as determined by either AST or ALT values > 2 times the upper limit of normal
- •History of gastrointestinal surgery or disorders which could interfere with drug absorption
- •Known allergy or contraindications to one of the drugs to be administered in the study
- •History of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years
- •History of clinically significant autoimmune disorders such as systemic lupus erythematosus.
- •History of drug or alcohol abuse within the last 5 years
- •History of non-compliance to medical regimens and/or patients who are considered potentially unreliable
- •Inability or unwillingness to give free informed consent
- •Pregnancy or planned pregnancy during study period.
结局指标
主要结局
changes in LVMI (co-primary endpoint)
时间窗: 12 months
UAE (albumin/creatinine ratio, co-primary end-point)
时间窗: 12 months
次要结局
未报告次要终点