Status:
ACTIVE_NOT_RECRUITING
Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)
Lead Sponsor:
Hospital Israelita Albert Einstein
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Diabetes Mellitus
High Blood Pressure
Eligibility:
All Genders
50+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
9479 Patients enrolled
Trial Details
Trial ID
NCT04040634
Start Date
August 8 2019
End Date
December 31 2025
Last Update
November 18 2025
Active Locations (32)
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1
Centro de Pesquisas Clínicas Dr Marco Mota
Maceió, Alagoas, Brazil, 57051-160
2
Instituto de Estudos E Pesquisas Clinicas Do Ceara
Fortaleza, Ceará, Brazil
3
Hospital Universitário Cassiano Antonio de Moraes
Vitória, Espírito Santo, Brazil, 29043-260
4
Centro de Pesquisas em Diabetes e Doenças Endocrino-Metabólicas
Fortaleza, Estado de Bahia, Brazil, 60430-350