Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8,000
- 试验地点
- 42
- 主要终点
- Primary composite outcome
研究概览
简要总结
The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (<130 mmHg, intensive treatment) than currently recommended (<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.
详细描述
Hypertension is highly prevalent in the adult population in China, and its burden is rapidly increasing among persons older than 60 years of age. Elevated blood pressure (BP) is an important public health concern which contributes to several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. Clinical trials have shown that a lower systolic blood pressure goal will lead to greater reduction in cardiovascular disease (CVD) incidence, but the effect of intensive treatment of systolic blood pressure below 120 mm Hg in reducing of CVD risk has long been debated. In particularly, among the elderly hypertensive patients aged 60 years or older, the most appropriate targets for blood pressure lowering to reduce cardiovascular events still remain uncertain.
The STEP trial will randomize about 8000 participants aged between 60 and 80 years with SBP≥140 mm Hg and <190 mm Hg, and without a history of atherothrombotic or hemorrhagic stroke. Target SBP goals are 110-130 vs 130-150 mm Hg, respectively. The purpose of the STEP trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (<130 mmHg, intensive treatment) than currently recommended (<150 mmHg, standard treatment) will reduce CVD risk among hypertensive patients between 60-80 years. Participants will be recruited at approximately 40 clinic centers in China within approximately a 1-year period, and will be followed for 4 years. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic BP between 140-190 mm Hg in the three screening visits or currently under anti-hypertension treatment；
- •An age of 60 - 80 years old；
- •Signed the written informed consent.
排除标准
- •Systolic BP≥190 mm Hg, or diastolic BP <60 mm Hg;
- •Known secondary cause of hypertension;
- •History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack [TIA]);
- •Hospitalization for myocardial infarction or unstable angina within the previous 6 months;
- •Coronary revascularization (PCI or CABG) within the previous 12 months;
- •Planned to perform coronary revascularization (PCI or CABG) in the future 12 months;
- •History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure；
- •NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months;
- •Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial;
- •Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease;
- •Uncontrolled diabetes (serum fasting glucose ≥200 mg/dl [11.1 mmol/L], HbA1>8%);
- •Lab tests indicating abnormal liver or kidney function (ALT more than 3 times the upper limit of normal value, or end stage renal disease (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) <30 mL/min, or serum creatine >2.5 mg/dl [>221 umol/L];
- •Severe somatic disease such as cancer;
- •Severe cognitive impairment or mental disorders;
- •Participating in other clinical trials.
研究组 & 干预措施
Intensive BP control
SBP within 110 - <130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - <130 mm Hg.
干预措施: Intensive BP control (Drug)
Standard BP control
SBP within 130 - <150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - <150 mm Hg.
干预措施: Standard BP control (Drug)
结局指标
主要结局
Primary composite outcome
时间窗: 4 years
A composite end-point comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), first occurrence of symptomatic stroke ( ischemic or hemorrhagic stroke), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass grafting \[CABG\]), atrial fibrillation, and death from cardiovascular causes.
次要结局
- First occurrence of symptomatic stroke ( ischemic or hemorrhagic)(4 years)
- Acute coronary syndrome(4 years)
- Hospitalization for acute decompensated heart failure(4 years)
- coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG])(4 years)
- Atrial fibrillation(4 years)
- Composite of major adverse cardiac events (primary outcome without stroke)(4 years)
- Cardiovascular death(4 years)
- First occurrence of diabetes mellitus(4 years)
- All-cause death(4 years)
- Decline in cognitive function(4 years)
- Decline in renal function or development of end stage renal disease (ESRD)(4 years)
- Major artery stiffness(4 years)
研究者
Jun Cai
Director, Hypertension Center
Chinese Academy of Medical Sciences, Fuwai Hospital