Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES)
概览
- 阶段
- 不适用
- 干预措施
- Intensive Control of Systolic Blood Pressure (SBP)
- 疾病 / 适应症
- Diabetes Mellitus
- 发起方
- Hospital Israelita Albert Einstein
- 入组人数
- 9476
- 试验地点
- 51
- 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
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
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.
研究者
入排标准
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
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.)
研究组 & 干预措施
Intensive Control of Systolic Blood Pressure (SBP)
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)
Standard Control of Systolic Blood Pressure (SBP)
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)
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)