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Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)
Sponsor: Hospital Israelita Albert Einstein
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.
Official title: Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
9476
Start Date
2019-08-08
Completion Date
2026-05-31
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
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
Standard control of Systolic Blood Pressure (SBP)
The same medications used in the Intensive BP arm will be used for the Standard BP arm.
Locations (32)
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
Medicina Nuclear Alto da XV
Curitiba, Paraná, Brazil
Hospital Universitário João de Barros Barreto - UFPA
Belém, Pará, Brazil
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares da Silva
Recife, Pernambuco, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Clínica do Coração
Aracaju, Sergipe, Brazil
Centro de Endocrinologia Geloneze
Campinas, São Paulo, Brazil
Universidade Estadual de Campinas - UNICAMP
Campinas, São Paulo, Brazil
Indacor Servicos Medicos Ltda
Indaiatuba, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
Centro Integrado de Pesquisas
São José do Rio Preto, São Paulo, Brazil
Clínica Vilela & Martin
São José do Rio Preto, São Paulo, Brazil
Instituto de Cardiologia e Endocrinologia Rio Preto Ltda
São José do Rio Preto, São Paulo, Brazil
Clínica Cardiológica
Votuporanga, São Paulo, Brazil
Santa Casa de Misericordia de Votuporanga
Votuporanga, São Paulo, Brazil
Faculdade de Ciências Médicas - Universidade do Estado do Rio de Janeiro
Rio de Janeiro, Brazil
Clínica de Metabologia e Hipertensão da Universidade Federal de São Paulo
São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Irmandade Da Santa Casa de Misericordia de Sao Paulo
São Paulo, Brazil
Real e Benemérita Associação Portuguesa de Beneficência/SP
São Paulo, Brazil