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

This is an interventional treatment trial for Diabetes Mellitus Read More

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