HypertensionTrial design
Intensive blood-pressure control for the prevention of major cardiovascular events in patients with type 2 diabetes: Rationale, design and baseline characteristics of the OPTIMAL-DIABETES randomized trial
- multicentre, 2-arm, open-label, randomized clinical trial
- intention-to-treat
Study context
- Population
- Individuals aged ≥50 years, with a systolic BP (SBP) between 130 and 180 mm Hg, T2D and high cardiovascular (CV) risk, in Brazilparticipants from 33 sites in Brazil enrolled
- Participants
- 9,476 individuals
- Planned comparison
- a target of systolic blood pressure (BP) (SBP) < 120 mm Hg compared with a target of SBP < 140 mm Hg
- Primary endpoint
- Composite of:
- CV mortality
- Nonfatal myocardial infarction
- Nonfatal stroke
- Hospitalization for unstable angina
- Hospitalization for heart failure
- Follow-up
- Maximum is 48 months
No results yet. This paper sets out the design of a trial; its results are to come.
Baseline
Baseline characteristics
- Mean age, years (SD 8.16)
- 64.74
- Women
- 5,871 (62.0%)
- Mixed-race
- 4,025/9,467 (42.5%)
- White
- 3,971/9,467 (41.9%)
- Black
- 1,374/9,467 (14.5%)
- Established CV disease
- 2,697/9,475 (28.5%)
- Subclinical CV disease
- 371 (3.9%)
- Antihypertensive medication prescribed
- 9,104/9,473 (96.1%)
- Mean SBP, mm Hg (SD 12.13)
- 145.89
- Mean diastolic BP, mm Hg (SD 10.61)
- 79.48
- Enrollment August 2019 through October 2021
Original publication
Intensive blood-pressure control for the prevention of major cardiovascular events in patients with type 2 diabetes: Rationale, design and baseline characteristics of the OPTIMAL-DIABETES randomized trial. Am Heart J. Published 24 July 2026. doi:10.1016/j.ahj.2026.107545
Summarised from the published abstract; every number is checked against it