This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target \<120 mmHg versus \<140 mmHg.
This study is a multicenter, open-label, randomized controlled trial, which will randomize participants aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk. The study will compare the effects on the incidence of major cardiovascular events of allocation to achieve an intensive SBP goal (SBP \<120 mmHg) with a standard SBP goal (SBP \<140 mmHg) in four years of follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
11,255
Participants in the Intensive BP treatment group have a goal of SBP \<120 mmHg. It is recommended to provide long-acting antihypertensive medications, that is once daily, unless other medication delivery frequency is needed. The local investigator may select among the available study antihypertensive medications. Other drugs not supplied by the trial may also be used as the investigator determines appropriate. One or more medications from the following classes of agents will be provided by the study for use in managing participants in both randomization groups to achieve study goals: Angiotension converting enzyme (ACE)-inhibitors; Angiotension receptor blockers (ARBs); Thiazide-type diuretics; Loop diuretics; Potassium-sparing diuretics; Beta-blockers; Calcium channel blockers (CCBs); Direct vasodilators; Alpha1-receptor blockers; Sympatholytics
Participants in the Standard BP treatment group have a goal of SBP \<140 mmHg. The same medications used in the Intensive BP treatment group will be used for the Standard BP treatment group.
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Number of participants with composite of major CVD events
Composite outcome of myocardial infarction, coronary or non-coronary revascularization, chronic or acute decompensated heart failure hospitalization or emergency department visit, stroke, or death from cardiovascular disease
Time frame: 4 years
Number of participants with myocardial infarction
Time frame: 4 years
Number of participants with coronary revascularization
Time frame: 4 years
Number of participants with non-coronary revascularization
Time frame: 4 years
Number of participants with chronic or acute decompensated heart failure hospitalization or emergency department visit
Time frame: 4 years
Number of participants with stroke
Time frame: 4 years
Number of participants with cardiovascular death
Time frame: 4 years
Number of participants with all-cause death
Time frame: 4 years
Number of participants with composite outcome of the primary composite with all-cause death
Time frame: 4 years
Number of participants with end-stage kidney disease (ESKD), a sustained decline in eGFR to <10 mL/min/1.73m2, renal death, or a sustained decline of ≥40% in eGFR from randomization
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Time frame: 4 years
Number of participants with all-cause dementia or mild cognitive impairment
Time frame: 4 years
Difference of arteriole-to-venule ratio measured by fundus photography between intensive treatment group and standard treatment group
Time frame: at 4-year final follow-up visit