Blood Pressure Control Target in Diabetes (BPROAD): a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12,821
- 试验地点
- 1
- 主要终点
- Major cardiovascular events
研究概览
简要总结
This is a multicenter, open-label, parallel-group, randomized controlled trial that will be conducted across mainland China. This trial will test the primary hypothesis of whether an intensive treatment strategy (a systolic blood pressure target of <120 mmHg) is more effective than a standard treatment strategy (a systolic blood pressure target of <140 mmHg) in reducing the risk of major cardiovascular disease (non-fatal stroke, non-fatal myocardial infarction, treated or hospitalized heart failure, and cardiovascular deaths) over a follow-up period of up to 5 years among patients with a history of diabetes and elevated systolic blood pressure. The secondary hypotheses are to compare the intensive blood pressure treatment strategy with the standard treatment strategy on cognitive function, individual components of the primary hypothesis, all-cause mortality, kidney outcomes, quality of life, and injurious falls, et al.
详细描述
The trial will recruit 12,702 patients from approximately 150 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged ≥50 years; type 2 diabetes mellitus; elevated systolic blood pressure; and a history of clinical cardiovascular disease or increased risk for cardiovascular disease. Main exclusion criteria include known secondary cause of hypertension, symptomatic heart failure, end-stage renal disease, and other serious illness. The proposed trial has 90% statistical power to detect a 20% reduction (hazard ratio of 0.80) in major cardiovascular disease between intensive and standard treatment groups at a 2-sided significance level of 0.05.
To achieve the proposed study objectives, the following specific aims will be accomplished:
- Recruit 12,702 study participants who meet the eligibility criteria and randomly assign 6,351 to the intensive blood pressure treatment and 6,351 to the standard blood pressure treatment groups;
- Achieve and maintain two-level targets of systolic blood pressure (<120 mmHg vs. <140 mmHg) with a mean systolic blood pressure difference of ≥15 mmHg;
- Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and dyslipidemia other than blood pressure;
- Obtain clinical data on study outcomes for up to 60 months of follow-up among all trial participants;
- Perform strict quality control procedures for intervention and data collection;
- Conduct data analysis according to the intention-to-treat principle; and
- Disseminate the study findings to influence clinical practice and clinical guidelines.
Findings from this trial will provide evidence as to whether intensive blood pressure management to achieve a systolic blood pressure target of <120 mmHg has additional benefits over standard management of systolic blood pressure <140 mmHg. These findings will help in the development of clinical guidelines for blood pressure management among patients with type 2 diabetes and will have important clinical impact.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥50 years;
- •Diabetes defined as:
- •A self-reported previous diagnosis by health care professionals and taking anti-diabetic medications;
- •Fasting plasma glucose level of ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours;
- •2-hour plasma glucose level of ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test. The test should be performed using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water; or
- •HbA1c concentration of ≥6.5% (48 mmol/mol);
- •Systolic blood pressure
- •≥140 mmHg on 0 medication;
- •130-180 mmHg on 1 medication;
- •130-170 mmHg on up to 2 medications;
- •130-160 mmHg on up to 3 medications; or
- •130-150 mmHg on up to 4 medications;
- •Increased risk of cardiovascular disease (one or more of the following):
- •Previous history of clinical CVD (≥ 3 months)
- •Subclinical CVD within 3 years
- •2 or more CVD risk factors
- •Estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m2
排除标准
- •History consistent with type 1 diabetes
- •Known secondary cause of hypertension
- •One minute standing systolic BP <110 mmHg
- •Arm circumference too large to allow accurate blood pressure measurement with available devices
- •Cardiovascular event or procedure or hospitalization for unstable angina within the past 3 months
- •Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) <35% within the past 6 months
- •ALT or AST levels more than twice the upper limit of the normal range or active liver diseases
- •Dialysis, kidney transplantation, eGFR <30 ml/min/1.73 m2, or serum creatinine >2.0 mg/dl
- •Proteinuria
- •Previous diagnosis of polycystic kidney disease or glomerulonephritis
- •A medical condition likely to limit survival to less than 5 years
- •Any factors judged by the clinic team to be likely to limit adherence to interventions
- •Failure to obtain informed consent from participant
- •Currently participating in another intervention study
- •Currently living with another BPROAD participant
- •Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control
研究组 & 干预措施
Intensive BP treatment arm
Participants in the intensive BP treatment arm will be treated to a systolic BP target of <120 mmHg.
干预措施: Treatment strategy regarding different systolic BP goals (Other)
Standard BP treatment arm
Participants in the standard BP treatment arm will be treated to a systolic BP target of <140 mmHg.
干预措施: Treatment strategy regarding different systolic BP goals (Other)
结局指标
主要结局
Major cardiovascular events
时间窗: 5 years
Time to the first occurrence of any of the following: non-fatal stroke, non-fatal myocardial infarction, hospitalized or treated heart failure, or cardiovascular deaths
次要结局
- Total MI(5 years)
- Total stroke(5 years)
- Ischemic stroke(5 years)
- Hemorrhagic stoke(5 years)
- Cardiovascular death(5 years)
- Total mortality(5 years)
- A composite of the primary outcome and all-cause mortality(5 years)
- Macrovascular outcome(5 years)
- Major coronary artery diseases(5 years)
- Heart failure(5 years)
- Cognitive function(5 years)
- Health related quality of life(5 years)
- Kidney outcomes(5 years)
研究者
Guang Ning
Professor
Shanghai Jiao Tong University School of Medicine