| Trial name or title | STEP Study |
| Methods | Multicentre, prospective, randomized, open‐labelled, blinded‐end point trial. The follow‐up period will be 4 years |
| Participants | Men and women aged 60 to 80 years, with SBP between 140 and 190 mm Hg in the three screening visits or currently under antihypertensive treatment and signed the written informed content. Exclusion criteria: SBP ≥190 mm Hg or DBP < 60 mm Hg; known secondary cause of hypertension; history of large atherosclerotic cerebral infarction or haemorrhagic stroke (not lacunar infarction and TIA); hospitalization for MI or unstable angina within the previous 6 months; coronary revascularization (PCI or CABG) within the previous 12 months; planned to perform coronary revascularization (PCI or CABG) in the next 12 months; history of sustained atrial fibrillation or ventricular arrhythmias at entry influencing the measurement of electronic blood pressure; NYHA class III‐IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months; severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial; dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease; uncontrolled diabetes (serum fasting glucose ≥ 200 mg/dL (11.1 mmol/L, HbA1c > 8%); lab tests indicating abnormal liver or kidney function (ALT > 3 times the upper limit of normal value, or ESKD on dialysis, or eGFR < 30 mL/min, or sCr > 2.5 mg/dL (> 221 µmol/L); severe somatic disease such as cancer; severe cognitive impairment or mental disorders; participating in other clinical trials |
| Interventions | Standard target: 130 to 149 mmHg Intensive target: 110 to 129 mmHg |
| Outcomes | Primary outcome measures: A composite end point comprised of MI, first occurrence of symptomatic stroke (ischaemic or haemorrhagic, fatal or non fatal), hospitalization for unstable angina or acute decompensated heart failure, coronary revascularization (PCI, CABG)), and death from cardiovascular causes. Secondary outcome measures: Major coronary events comprised of MI, hospitalization for unstable angina or acute decompensated heart failure, coronary revascularization (PCI, CABG), and death from cardiovascular causes; first occurrence of symptomatic stroke (ischaemic or haemorrhagic, fatal or non fatal); all‐cause death; cardiovascular death; MI; hospitalization for unstable angina; hospitalization for acute decompensated heart failure; coronary revascularization (PCI, CABG); first occurrence of diabetes mellitus; decline in cognitive function; decline in renal function or development of ESKD; major artery function changes |
| Starting date | December 2016 |
| Contact information | Weili Zhang, MD (zhangweili1747@yahoo.com); Guomei Wu (wuguomei513@163.com) |
| Notes |
Abbreviations: ALT ‐ alanine aminotransferase; CABG ‐ coronary artery bypass graft; CHD ‐ coronary heart disease; CHF ‐ congestive heart failure; CVD ‐ cardiovascular disease; DBP ‐ diastolic blood pressure; eGFR ‐ estimated glomerular filtration rate; ESKD ‐ end‐stage kidney disease; LDL‐C ‐ low density lipoprotein cholesterol; MI ‐ myocardial infarction; MRI ‐ magnetic resonance imaging; MRI DWI ‐ magnetic resonance imaging diffusion weighted imaging; PCI ‐ percutaneous coronary intervention; SBP ‐ systolic blood pressure.