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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
9,476
Participants in the Intensive arm have a goal of SBP \<120 mm Hg. The use of angiotensin converting enzyme (ACE) inhibitors/angiotension receptor blockers (ARB), thiazide-type diuretics, and calcium channel blockers (CCB) will be encouraged, preferably fixed-dose combinations of indapamide + perindopril arginine, perindopril arginine + amlodipine or indapamide + perindopril arginine + amlodipine
The same medications used in the Intensive BP arm will be used for the Standard BP arm.
Centro de Pesquisas Clínicas Dr Marco Mota
Maceió, Alagoas, Brazil
Centro de Pesquisas em Diabetes e Doenças Endocrino-Metabólicas
Fortaleza, Ceará, Brazil
Instituto de Estudos E Pesquisas Clinicas Do Ceara
Fortaleza, Ceará, Brazil
Hospital Universitário Cassiano Antonio de Moraes
Vitória, Espírito Santo, Brazil
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
Time to first event of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
Time frame: From randomization to 48 months
Time to cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke
Time to first event of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke
Time frame: 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
Time to first event of total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
Time frame: From randomization to 48 months
Time to Death
Time to all cause death
Time frame: From randomization to 48 months
Time to Cardiovascular Death
Time to death from cardiovascular causes
Time frame: From randomization to 48 months
Time to Renal Death
Time to death from renal causes
Time frame: From randomization to 48 months
Time to Myocardial Infarction (MI)
Time to myocardial infarction (MI)
Time frame: From randomization to 48 months
Time to Stroke
Time to stroke
Time frame: From randomization to 48 months
Time to Ischemic Stroke
Time to ischemic stroke
Time frame: Follow-up of 48 months
Time to Hemorrhagic Stroke
Time to hemorrhagic stroke
Time frame: From randomization to 48 months
Time to Undetermined type of Stroke
Time to Undetermined type of Stroke
Time frame: From randomization to 48 months
Time to Transient Ischemic Attack (TIA)
Time to transient ischemic attack (TIA)
Time frame: From randomization to 48 months
Time to Hospitalization for Unstable Angina
Time to Hospitalization for unstable angina
Time frame: From randomization to 48 months
Time to Hospitalization for Heart Failure
Time to hospitalization for heart failure
Time frame: From randomization to 48 months
Time to Renal Outcome
Time to Renal Outcome, defined as a ≥50% reduction in the glomerular filtration rate (GFR) from baseline (excluding acute reversible causes) or progression to end-stage renal disease, which is defined as a GFR \< 15 mL/min/1.73m² (excluding reversible causes) or the need for dialysis (hemodialysis or peritoneal dialysis for at least 30 days) or kidney transplantation
Time frame: From randomization to 48 months
Cognitive Impairment
Decline in the Montreal Cognitive Assessment (MoCA) score calculated as the difference between initial and last assessments
Time frame: From randomization to 48 months
Time to Mild Cognitive Impairment
Time to Mild Cognitive Impairment
Time frame: From randomization to 48 months
Time to Mild Cognitive Impairment or All-Cause Probable Dementia
Time to mild cognitive impairment or all-cause probable dementia
Time frame: From randomization to 48 months
Time to All-Cause Probable Dementia
Time to all-cause probable dementia
Time frame: From randomization to 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Instituto Hospital de Base
Brasília, Federal District, Brazil
Universidade Federal de Goiás
Goiânia, Goiás, Brazil
NS Clínica de Diabetes e Endocrinologia Ltda
Goiânia, Goiás, Brazil
Hospital das Clinicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Centro de Pesquisa do Hospital Santa Lúcia
Poços de Caldas, Minas Gerais, Brazil
...and 22 more locations