At a glance
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Blood Pressure Control Target in Diabetes (BPROAD): a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial
In Brief
A clinical study evaluating Treatment strategy regarding different systolic BP goals for Blood Pressure Control Target in Diabetes. Completed, enrolled 12,821 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
The trial will test a treatment strategy question regarding different systolic BP goals and not test specific medications. Therefore, the BP treatment protocol is flexible in terms of the choice and doses of anti-hypertensive medications as long as systolic BP levels are within targets (\<120 mmHg in the intensive arm and \<140 mmHg in the standard arm).