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Diabetes MellitusNCT04040634

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

A study of Diabetes Mellitus and High Blood Pressure, run by Hospital Israelita Albert Einstein at 32 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,476 participants
Where
32 sitesBrazil
Study dates
8 Aug 2019to 8 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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
  • 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.
  • Chronic kidney disease (CKD):
  • Definition of CKD: glomerular filtration rate (GFR) between 20 and 59 ml/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
  • Additional cardiovascular risk factors, including:
  • Active smoking: Defined as regular use of cigarettes or other tobacco products, such as cigars and pipe, in the last six months;
  • Dyslipidemia: Defined as LDL cholesterol > 70 mg/dL or non-HDL cholesterol > 100 mg/dL in patients with previous CVD; or LDL cholesterol > 100 mg/dL or non-HDL cholesterol > 130 mg/dL in patients without previous CVD; or Triglycerides > 200 mg/dL or HDL < 40 mg/dL regardless of treatment; or use of statins or other lipid lowering medication; or
  • Age ≥ 75 years

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Pregnancy or breastfeeding

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Brazil32 sites

  • Centro de Pesquisa Clínica do Coração

    Aracaju, Sergipe, 49055-530

  • Hospital Universitário João de Barros Barreto - UFPA

    Belém, Pará

  • Hospital das Clinicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

  • Instituto Hospital de Base

    Brasília, Federal District, 70330-150

  • Centro de Endocrinologia Geloneze

    Campinas, São Paulo, 13073-350

  • Universidade Estadual de Campinas - UNICAMP

    Campinas, São Paulo

  • Medicina Nuclear Alto da XV

    Curitiba, Paraná

  • Centro de Pesquisas em Diabetes e Doenças Endocrino-Metabólicas

    Fortaleza, Ceará, 60430-350

  • Instituto de Estudos E Pesquisas Clinicas Do Ceara

    Fortaleza, Ceará

  • Universidade Federal de Goiás

    Goiânia, Goiás, 74605-020

  • NS Clínica de Diabetes e Endocrinologia Ltda

    Goiânia, Goiás, 90020-090

  • Indacor Servicos Medicos Ltda

    Indaiatuba, São Paulo

  • Centro de Pesquisas Clínicas Dr Marco Mota

    Maceió, Alagoas, 57051-160

  • Centro de Pesquisa do Hospital Santa Lúcia

    Poços de Caldas, Minas Gerais, 37710-005

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares da Silva

    Recife, Pernambuco, 50100-060

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

    Ribeirão Preto, São Paulo, 14048-900

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

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Hospital Ana Nery

    Salvador, Estado de Bahia, 40323-010

  • Centro Integrado de Pesquisas

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

  • Clínica Vilela & Martin

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

  • Instituto de Cardiologia e Endocrinologia Rio Preto Ltda

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

  • Clínica de Metabologia e Hipertensão da Universidade Federal de São Paulo

    São Paulo, São Paulo, 04025-010

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

    São Paulo, São Paulo, 05403-000

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

    São Paulo, São Paulo, 05403-000

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, São Paulo

  • Irmandade Da Santa Casa de Misericordia de Sao Paulo

    São Paulo, São Paulo

  • Real e Benemérita Associação Portuguesa de Beneficência/SP

    São Paulo, São Paulo

  • Hospital Universitário Cassiano Antonio de Moraes

    Vitória, Espírito Santo, 29043-260

  • Clínica Cardiológica

    Votuporanga, São Paulo, 15505-189

  • Santa Casa de Misericordia de Votuporanga

    Votuporanga, São Paulo

Other trials in Brazil

About this study

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)

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.

Being tested
Intensive Control of Systolic Blood Pressure (SBP), Standard control of Systolic Blood Pressure (SBP)
Medical subject headings
Diabetes Mellitus, Hypertension, Cardiovascular Diseases, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Control of Systolic Blood Pressure (SBP)Drug

    Also called Intensive BP control targeting SBP <120 mm Hg

    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)Drug

    Also called Standard control of SBP targeting SBP < 140 mm Hg

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

Study groups in NCT04040634
Study groupRoleWhat they receive
Intensive Control of Systolic Blood Pressure (SBP)ExperimentalParticipants randomized into the Intensive Blood Pressure arm will have a goal of SBP <120 mm Hg.
Receives: Drug: Intensive Control of Systolic Blood Pressure (SBP)
Standard Control of Systolic Blood Pressure (SBP)Active comparatorParticipants randomized into the Standard arm will have a goal of SBP <140 mm Hg.
Receives: Drug: Standard control of Systolic Blood Pressure (SBP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From randomization to 48 months

Secondary outcomes (18)

  1. Time to cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke

    Time to first event of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke

    Measured: From randomization to 48 months

  2. Time to total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure

    Time to first event of total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure

    Measured: From randomization to 48 months

  3. Time to Death

    Time to all cause death

    Measured: From randomization to 48 months

  4. Time to Cardiovascular Death

    Time to death from cardiovascular causes

    Measured: From randomization to 48 months

  5. Time to Renal Death

    Time to death from renal causes

    Measured: From randomization to 48 months

  6. Time to Myocardial Infarction (MI)

    Time to myocardial infarction (MI)

    Measured: From randomization to 48 months

  7. Time to Stroke

    Time to stroke

    Measured: From randomization to 48 months

  8. Time to Ischemic Stroke

    Time to ischemic stroke

    Measured: Follow-up of 48 months

  9. Time to Hemorrhagic Stroke

    Time to hemorrhagic stroke

    Measured: From randomization to 48 months

  10. Time to Undetermined type of Stroke

    Time to Undetermined type of Stroke

    Measured: From randomization to 48 months

  11. Time to Transient Ischemic Attack (TIA)

    Time to transient ischemic attack (TIA)

    Measured: From randomization to 48 months

  12. Time to Hospitalization for Unstable Angina

    Time to Hospitalization for unstable angina

    Measured: From randomization to 48 months

  13. Time to Hospitalization for Heart Failure

    Time to hospitalization for heart failure

    Measured: From randomization to 48 months

  14. Time to Renal Outcome

    Time to Renal Outcome, defined as a ≥50% reduction in the glomerular filtration rate (GFR) from baseline (excluding acute reversible causes) or progression to end-stage renal disease, which is defined as a GFR < 15 mL/min/1.73m² (excluding reversible causes) or the need for dialysis (hemodialysis or peritoneal dialysis for at least 30 days) or kidney transplantation

    Measured: From randomization to 48 months

  15. Cognitive Impairment

    Decline in the Montreal Cognitive Assessment (MoCA) score calculated as the difference between initial and last assessments

    Measured: From randomization to 48 months

  16. Time to Mild Cognitive Impairment

    Time to Mild Cognitive Impairment

    Measured: From randomization to 48 months

  17. Time to Mild Cognitive Impairment or All-Cause Probable Dementia

    Time to mild cognitive impairment or all-cause probable dementia

    Measured: From randomization to 48 months

  18. Time to All-Cause Probable Dementia

    Time to all-cause probable dementia

    Measured: From randomization to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2019
  2. Study start8 Aug 2019
  3. Primary completion8 Jul 2026
  4. Study completion8 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
9,476 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04040634
Sponsor's protocol ID
OPTIMAL-DIABETES Trial
Other IDs
02795218.8.1001.0071, 25000.028978/2018-02
Status last verified
Oct 2025
First submitted
30 Jul 2019
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Santo K, Martins E, Silva GS, Guimaraes PO, Tavares CAM, Brainer J, Monfardini F, Nieri J, Assis SRL, Felicio JS, Silveira FS, Feitosa ADM, Hissa MN, Sobral-Filho DC, Vilela-Martin JF, Cestario EES, Yugar-Toledo JC, Batista MC, Turatti L, Brandao AA, Barroso WS, Sposito AC, Drager LF, Bortolotto LA, Fuchs SC, Franken M, Lemos PA, Santos RD, Rodgers A, Whelton PK, Fuchs FD, Berwanger O. Intensive Blood-Pressure Control for the Prevention of Major Cardiovascular Events in Patients with Type 2 Diabetes: Rationale, Design and Baseline Characteristics of the OPTIMAL-DIABETES Randomized Trial. Am Heart J. 2026 Jul 24:107545. doi: 10.1016/j.ahj.2026.107545. Online ahead of print.

    PubMed 42498010

  • 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.

    PubMed 36398903

  • 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.

    PubMed 32905623

Questions about this trial

What is this clinical trial studying?

A study of Diabetes Mellitus and High Blood Pressure, run by Hospital Israelita Albert Einstein at 32 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure (time frame: From randomization to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04040634, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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