Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can tighter blood pressure control save hearts in diabetes? massive trial aims to find out

NCT ID NCT04040634

Disease control Sponsor: Hospital Israelita Albert Einstein Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This large study is testing whether a lower blood pressure target can reduce major heart problems like heart attacks, strokes, and heart failure in people with type 2 diabetes. About 9,500 participants with high blood pressure and high cardiovascular risk are being randomly assigned to either a standard or a more intensive blood pressure goal. The study also looks at effects on thinking and memory.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9,476 people

The number who actually took part.

Started

Aug 2019

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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. 2. 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. 3. 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). 4. 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 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.) * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiovascular diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cardiovascular disorder chronic kidney disease Cognitive Dysfunction diabetes mellitus hypertensive disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Cognitive impairment Diabetes mellitus High blood pressure

Contacts and locations

Locations

  • Centro Integrado de Pesquisas

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

  • Centro de Endocrinologia Geloneze

    Campinas, São Paulo, 13073-350, Brazil

  • Centro de Pesquisa Clínica do Coração

    Aracaju, Sergipe, 49055-530, Brazil

  • Centro de Pesquisa do Hospital Santa Lúcia

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

  • Centro de Pesquisas Clínicas Dr Marco Mota

    Maceió, Alagoas, 57051-160, Brazil

  • Centro de Pesquisas em Diabetes e Doenças Endocrino-Metabólicas

    Fortaleza, Ceará, 60430-350, Brazil

  • Clínica Cardiológica

    Votuporanga, São Paulo, 15505-189, Brazil

  • Clínica Vilela & Martin

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

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

    São Paulo, São Paulo, 04025-010, Brazil

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

    Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

  • Hospital Ana Nery

    Salvador, Estado de Bahia, 40323-010, Brazil

  • Hospital São Lucas da PUCRS

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

  • Hospital Universitário Cassiano Antonio de Moraes

    Vitória, Espírito Santo, 29043-260, Brazil

  • Hospital Universitário João de Barros Barreto - UFPA

    Belém, Pará, Brazil

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

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Hospital das Clinicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

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

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital de Clínicas de Porto Alegre

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

  • Indacor Servicos Medicos Ltda

    Indaiatuba, São Paulo, Brazil

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, São Paulo, Brazil

  • Instituto Hospital de Base

    Brasília, Federal District, 70330-150, Brazil

  • Instituto de Cardiologia e Endocrinologia Rio Preto Ltda

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

  • Instituto de Estudos E Pesquisas Clinicas Do Ceara

    Fortaleza, Ceará, Brazil

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

    São Paulo, São Paulo, 05403-000, Brazil

  • Irmandade Da Santa Casa de Misericordia de Sao Paulo

    São Paulo, São Paulo, Brazil

  • Medicina Nuclear Alto da XV

    Curitiba, Paraná, Brazil

  • NS Clínica de Diabetes e Endocrinologia Ltda

    Goiânia, Goiás, 90020-090, Brazil

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

    Recife, Pernambuco, 50100-060, Brazil

  • Real e Benemérita Associação Portuguesa de Beneficência/SP

    São Paulo, São Paulo, Brazil

  • Santa Casa de Misericordia de Votuporanga

    Votuporanga, São Paulo, Brazil

  • Universidade Estadual de Campinas - UNICAMP

    Campinas, São Paulo, Brazil

  • Universidade Federal de Goiás

    Goiânia, Goiás, 74605-020, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.