Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)

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.

NCT Number	NCT04040634
Lead Sponsor	Hospital Israelita Albert Einstein Collaborators: Ministry of Health, Brazil
Conditions	Diabetes Mellitus, High Blood Pressure, Cardiovascular Diseases, Cognitive Impairment
Enrollment	9,476 participants
Start Date	2019-08-08
Primary Completion	2026-07-08 (estimated)
Study Completion	2026-07-08 (estimated)
Updated on ClinicalTrials.gov	2026-08-04