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

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Criteria

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.