Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES)

Official Summary

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 Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 9,476 participants

Interventions

• DRUG: Intensive Control of Systolic Blood Pressure (SBP) — 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
• DRUG: Standard control of Systolic Blood Pressure (SBP) — The same medications used in the Intensive BP arm will be used for the Standard BP arm.

Primary Outcomes

• Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure (From randomization to 48 months)

Secondary Outcomes

• Time to cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke (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 (From randomization to 48 months)
• Time to Death (From randomization to 48 months)
• Time to Cardiovascular Death (From randomization to 48 months)
• Time to Renal Death (From randomization to 48 months)

Trial Locations

• 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
• 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 10 more locations

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