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Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

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

NCT04040634•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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Systolic Blood Pressure (SBP) between 130 and 180 mm Hg:
•* 130 to 150 mm Hg (if on 0-4 medications)
•* 130 to 160 mm Hg (if on 0-3 medications)
•* 130 to 170 mm Hg (if on 0-2 medications)
•* 130 to 180 mm Hg (if on 0-1 medications)
•Type 2 diabetes
•To be considered as having a high cardiovascular risk, including AT LEAST ONE of the following factors:
•1. Established cardiovascular disease (CVD), including:
•* Coronary artery disease: previous myocardial infarction, previous acute coronary syndrome, previous percutaneous coronary intervention, previous coronary artery bypass graft surgery, or at least 50% stenosis in a main coronary artery associated with typical angina pectoris; or
•* Cerebrovascular disease: previous stroke (except those events caused by intracranial aneurysm or arteriovenous malformation) or previous transient ischemic attack (TIA), stable for at least 2 weeks preceding inclusion in the study; or
+12 more criteria

Exclusion Criteria

•Refusal to provide written informed consent
•Body mass index \> 45 kg/m2
•Known secondary cause of hypertension
•Severe renal dysfunction with GFR \< 20 mL/min/1.73m2 calculated by the CKD-EPI equation
•Angina at rest Class IV Canadian Cardiovascular Society (CCS)
•Acute coronary syndrome in the last six months
•Symptomatic heart failure Class IV New York Heart Association (NYHA) or ejection fraction \< 35% on Doppler echocardiography in the last six months
•Factors that at the research team´s judgment may limit adherence to the intervention and study protocol, including, but not limited to, the following examples:
•* Recent history of alcohol and illicit drug abuse
•* Psychiatric comorbidities (severe depression, schizophrenia, psychosis, etc.)
+6 more criteria

Locations (32)

Centro de Pesquisas Clínicas Dr Marco Mota

Maceió, Alagoas, Brazil

Instituto de Estudos E Pesquisas Clinicas Do Ceara

Fortaleza, Ceará, Brazil

Hospital Universitário Cassiano Antonio de Moraes

Vitória, Espírito Santo, Brazil

Centro de Pesquisas em Diabetes e Doenças Endocrino-Metabólicas

Fortaleza, Estado de Bahia, 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

Key Dates

Start Date

August 8, 2019

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

November 18, 2025

Enrollment

9,479

ACTUAL participants

Conditions

Diabetes MellitusHigh Blood PressureCardiovascular DiseasesCognitive Impairment

Interventions

Intensive Control of Systolic Blood Pressure (SBP)

DRUG

Standard control of Systolic Blood Pressure (SBP)

DRUG

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

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RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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