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ACTIVE NOT RECRUITING
NCT04040634
NA

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

Sponsor: Hospital Israelita Albert Einstein

View on ClinicalTrials.gov

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

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.

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