NCT04040634

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,476

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
1mo left

Started Aug 2019

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

32 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2019May 2026

First Submitted

Initial submission to the registry

July 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

March 27, 2026

Status Verified

October 1, 2025

Enrollment Period

6.8 years

First QC Date

July 30, 2019

Last Update Submit

March 24, 2026

Conditions

Diabetes MellitusHigh Blood PressureCardiovascular DiseasesCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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

    From randomization to 48 months

Secondary Outcomes (18)

  • 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

  • +13 more secondary outcomes

Study Arms (2)

Intensive Control of Systolic Blood Pressure (SBP)

EXPERIMENTAL

Participants randomized into the Intensive Blood Pressure arm will have a goal of SBP \<120 mm Hg.

Drug: Intensive Control of Systolic Blood Pressure (SBP)

Standard Control of Systolic Blood Pressure (SBP)

ACTIVE COMPARATOR

Participants randomized into the Standard arm will have a goal of SBP \<140 mm Hg.

Drug: Standard control of Systolic Blood Pressure (SBP)

Interventions

Intensive Control of Systolic Blood Pressure (SBP)DRUG

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

Also known as: Intensive BP control targeting SBP <120 mm Hg
Intensive Control of Systolic Blood Pressure (SBP)
Standard control of Systolic Blood Pressure (SBP)DRUG

The same medications used in the Intensive BP arm will be used for the Standard BP arm.

Also known as: Standard control of SBP targeting SBP < 140 mm Hg
Standard Control of Systolic Blood Pressure (SBP)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systolic Blood Pressure (SBP) between 130 and 180 mm Hg:
  • to 150 mm Hg (if on 0-4 medications)
  • to 160 mm Hg (if on 0-3 medications)
  • to 170 mm Hg (if on 0-2 medications)
  • 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:
  • 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
  • Carotid artery disease: previous carotid endarterectomy, previous percutaneous intervention with carotid stent implantation, or stenosis of at least 50% in a carotid shown by the Doppler ultrasonography, CT angiography or MR angiography; or
  • Peripheral artery disease: prior surgical or percutaneous revascularization of a peripheral artery, limb amputation due to vascular cause, abdominal aortic aneurysm ≥ 5 cm (with or without prior surgical or percutaneous repair), or stenosis of at least 50% in a peripheral artery associated to intermittent claudication.
  • Subclinical CVD, including:
  • Coronary calcium score ≥ 300 Agatston units; or
  • Ankle-brachial index ≤ 0.90 in the last two years; or
  • Left ventricular hypertrophy on the electrocardiogram, echocardiogram or other cardiac imaging exam in the last two years.
  • +6 more criteria

You may not qualify if:

  • 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.)
  • History of poor medication adherence and attendance to consultations
  • Any plans to move the city of residence in the next four years
  • Any plans to leave the city of residence for more than three months in the next few years
  • Living in the same residence of another patient previously included in this study
  • Patients currently enrolled in another study for CVD prevention, including those evaluating pharmacological and non-pharmacological interventions
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Centro de Pesquisas Clínicas Dr Marco Mota

Maceió, Alagoas, 57051-160, Brazil

Location

Centro de Pesquisas em Diabetes e Doenças Endocrino-Metabólicas

Fortaleza, Ceará, 60430-350, Brazil

Location

Instituto de Estudos E Pesquisas Clinicas Do Ceara

Fortaleza, Ceará, Brazil

Location

Hospital Universitário Cassiano Antonio de Moraes

Vitória, Espírito Santo, 29043-260, Brazil

Location

Hospital Ana Nery

Salvador, Estado de Bahia, 40323-010, Brazil

Location

Instituto Hospital de Base

Brasília, Federal District, 70330-150, Brazil

Location

Universidade Federal de Goiás

Goiânia, Goiás, 74605-020, Brazil

Location

NS Clínica de Diabetes e Endocrinologia Ltda

Goiânia, Goiás, 90020-090, Brazil

Location

Hospital das Clinicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Centro de Pesquisa do Hospital Santa Lúcia

Poços de Caldas, Minas Gerais, 37710-005, Brazil

Location

Medicina Nuclear Alto da XV

Curitiba, Paraná, Brazil

Location

Hospital Universitário João de Barros Barreto - UFPA

Belém, Pará, Brazil

Location

Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares da Silva

Recife, Pernambuco, 50100-060, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Centro de Pesquisa Clínica do Coração

Aracaju, Sergipe, 49055-530, Brazil

Location

Centro de Endocrinologia Geloneze

Campinas, São Paulo, 13073-350, Brazil

Location

Universidade Estadual de Campinas - UNICAMP

Campinas, São Paulo, Brazil

Location

Indacor Servicos Medicos Ltda

Indaiatuba, São Paulo, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Centro Integrado de Pesquisas

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Clínica Vilela & Martin

São José do Rio Preto, São Paulo, 15090-365, Brazil

Location

Instituto de Cardiologia e Endocrinologia Rio Preto Ltda

São José do Rio Preto, São Paulo, 15091-330, Brazil

Location

Clínica Cardiológica

Votuporanga, São Paulo, 15505-189, Brazil

Location

Santa Casa de Misericordia de Votuporanga

Votuporanga, São Paulo, Brazil

Location

Faculdade de Ciências Médicas - Universidade do Estado do Rio de Janeiro

Rio de Janeiro, 20551-030, Brazil

Location

Clínica de Metabologia e Hipertensão da Universidade Federal de São Paulo

São Paulo, 04025-010, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

Location

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Irmandade Da Santa Casa de Misericordia de Sao Paulo

São Paulo, Brazil

Location

Real e Benemérita Associação Portuguesa de Beneficência/SP

São Paulo, Brazil

Location

Related Publications (2)

  • Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.

    PMID: 36398903DERIVED

  • Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.

    PMID: 32905623DERIVED

MeSH Terms

Conditions

Diabetes MellitusHypertensionCardiovascular DiseasesCognitive Dysfunction

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Otavio Berwanger, MD, PhD

    Hospital Israelita Albert Einstein

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 1, 2019

Study Start

August 8, 2019

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

March 27, 2026

Record last verified: 2025-10

Locations

BR(32)