NCT04040634已完成不适用
Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,476
- 试验地点
- 60
- 主要终点
- Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
研究概览
简要总结
High blood pressure (BP) is a major public health concern, especially in low and middle income countries. High BP is a highly prevalent condition, and it is usually associated with diabetes mellitus. Both high BP and diabetes are risk factors for major cardiovascular events including cardiovascular death, acute myocardial infarction, stroke, unstable angina and heart failure. In addition, high BP is also related to cognitive decline. The OPTIMAL-DIABETES trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower systolic blood pressure (SBP) target will reduce the occurrence of major cardiovascular events in diabetic patients compared to the standard SBP target.
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
- •Systolic Blood Pressure (SBP) between 130 and 180 mm Hg:
- •130 to 150 mm Hg (if on 0-4 medications)
- •130 to 160 mm Hg (if on 0-3 medications)
- •130 to 170 mm Hg (if on 0-2 medications)
- •130 to 180 mm Hg (if on 0-1 medications)
- •Type 2 diabetes
- •To be considered as having a high cardiovascular risk, including AT LEAST ONE of the following factors:
- •Established cardiovascular disease (CVD), including:
- •Coronary artery disease: previous myocardial infarction, previous acute coronary syndrome, previous percutaneous coronary intervention, previous coronary artery bypass graft surgery, or at least 50% stenosis in a main coronary artery associated with typical angina pectoris; or
- •Cerebrovascular disease: previous stroke (except those events caused by intracranial aneurysm or arteriovenous malformation) or previous transient ischemic attack (TIA), stable for at least 2 weeks preceding inclusion in the study; or
- •Carotid artery disease: previous carotid endarterectomy, previous percutaneous intervention with carotid stent implantation, or stenosis of at least 50% in a carotid shown by the Doppler ultrasonography, CT angiography or MR angiography; or
- •Peripheral artery disease: prior surgical or percutaneous revascularization of a peripheral artery, limb amputation due to vascular cause, abdominal aortic aneurysm ≥ 5 cm (with or without prior surgical or percutaneous repair), or stenosis of at least 50% in a peripheral artery associated to intermittent claudication.
- •Subclinical CVD, including:
- •Coronary calcium score ≥ 300 Agatston units; or
- •Ankle-brachial index ≤ 0.90 in the last two years; or
- •Left ventricular hypertrophy on the electrocardiogram, echocardiogram or other cardiac imaging exam in the last two years.
- •Chronic kidney disease (CKD):
- •▪ Definition of CKD: glomerular filtration rate (GFR) between 20 and 59 ml/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
- •Additional cardiovascular risk factors, including:
- •Active smoking: Defined as regular use of cigarettes or other tobacco products, such as cigars and pipe, in the last six months;
- •Dyslipidemia: Defined as LDL cholesterol > 70 mg/dL or non-HDL cholesterol > 100 mg/dL in patients with previous CVD; or LDL cholesterol > 100 mg/dL or non-HDL cholesterol > 130 mg/dL in patients without previous CVD; or Triglycerides > 200 mg/dL or HDL < 40 mg/dL regardless of treatment; or use of statins or other lipid lowering medication; or
- •Age ≥ 75 years
排除标准
- •Refusal to provide written informed consent
- •Body mass index > 45 kg/m2
- •Known secondary cause of hypertension
- •Severe renal dysfunction with GFR < 20 mL/min/1.73m2 calculated by the CKD-EPI equation
- •Angina at rest Class IV Canadian Cardiovascular Society (CCS)
- •Acute coronary syndrome in the last six months
- •Symptomatic heart failure Class IV New York Heart Association (NYHA) or ejection fraction < 35% on Doppler echocardiography in the last six months
- •Factors that at the research team´s judgment may limit adherence to the intervention and study protocol, including, but not limited to, the following examples:
- •Recent history of alcohol and illicit drug abuse
- •Psychiatric comorbidities (severe depression, schizophrenia, psychosis, etc.)
- •History of poor medication adherence and attendance to consultations
- •Any plans to move the city of residence in the next four years
- •Any plans to leave the city of residence for more than three months in the next few years
- •Living in the same residence of another patient previously included in this study
- •Patients currently enrolled in another study for CVD prevention, including those evaluating pharmacological and non-pharmacological interventions
- •Pregnancy or breastfeeding
研究组 & 干预措施
Intensive Control of Systolic Blood Pressure (SBP)
Experimental
Participants randomized into the Intensive Blood Pressure arm will have a goal of SBP <120 mm Hg.
干预措施: Intensive Control of Systolic Blood Pressure (SBP) (Drug)
Standard Control of Systolic Blood Pressure (SBP)
Active Comparator
Participants randomized into the Standard arm will have a goal of SBP <140 mm Hg.
干预措施: Standard control of Systolic Blood Pressure (SBP) (Drug)
结局指标
主要结局
Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
时间窗: From randomization to 48 months
Time to first event of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
次要结局
- Time to Hemorrhagic Stroke(From randomization to 48 months)
- Time to cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke(From randomization to 48 months)
- Time to total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure(From randomization to 48 months)
- Time to Renal Death(From randomization to 48 months)
- Time to Ischemic Stroke(Follow-up of 48 months)
- Time to Undetermined type of Stroke(From randomization to 48 months)
- Time to Death(From randomization to 48 months)
- Time to Myocardial Infarction (MI)(From randomization to 48 months)
- Time to Stroke(From randomization to 48 months)
- Time to Transient Ischemic Attack (TIA)(From randomization to 48 months)
- Time to Mild Cognitive Impairment or All-Cause Probable Dementia(From randomization to 48 months)
- Time to All-Cause Probable Dementia(From randomization to 48 months)
- Time to Cardiovascular Death(From randomization to 48 months)
- Time to Hospitalization for Unstable Angina(From randomization to 48 months)
- Time to Hospitalization for Heart Failure(From randomization to 48 months)
- Time to Renal Outcome(From randomization to 48 months)
- Time to Mild Cognitive Impairment(From randomization to 48 months)
- Cognitive Impairment(From randomization to 48 months)
研究者
研究点 (60)
Loading locations...
相似试验
已完成
不适用
Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke PatientsIschemic StrokeBlood PressureCognitive ImpairmentVascular DiseasesNCT04036409Hospital Israelita Albert Einstein4,368
Unknown
3 期
Randomized Controlled Trial of Renal Denervation for Resistant HypertensionHypertensionNCT02900729Shanghai WiseGain Medical Devices Co., Ltd.254
Unknown
2 期
Investigating the Use of Genetics to Guide Pharmacologic Therapy for HypertensionHypertensionNCT02988245Geneticure, LLC1,000
已完成
不适用
Control of Blood Pressure and Risk Attenuation-rural Bangladesh, Pakistan, Sri Lanka, Feasibility StudyHypertensionNCT02341651Duke-NUS Graduate Medical School453
终止
不适用
WIreless Monitoring and Financial Incentives for Uncontrolled HYpertension (WIFHY) StudyHypertensionNCT03368417Duke-NUS Graduate Medical School42