Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension

Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension

STEP-Pre is to investigate the benefits of using anti-hypertensive drugs in the population with a blood pressure of 130-139/80-89 mmHg and evaluate the health economics.

STEP-Pre is a multi-center randomized clinical trial. The cohort will be randomized into the treatment group or control group with a 1:1 ratio. The treatment group will take anti-hypertensive medicine to control blood pressure under 130/80 mmHg. Both groups will take health care education.

STEP-Pre will last 4 years.

Inclusion Criteria:

• Stage 1 hypertension (blood pressure is in 130-139/80-89 mmHg);
• 35 - 64 years old
• Without taking antihypertensive medicine during screening
• Signed the written informed consent

Exclusion Criteria:

• took antihypertensive medicine within the last 1 month;
• History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack [TIA]);
• History of myocardial infarction or unstable angina or history of coronary revascularization (PCI or CABG);
• Lab tests indicating abnormal liver or kidney function (ALT ≥ 3 times the upper limit of normal value, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2);
• History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure；
• 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;
• Severe somatic disease such as cancer;
• Severe cognitive impairment or mental disorders;
• pregnant or breastfeeding, or planning to be pregnant;
• having organ transplantation;
• Participating in other clinical trials.