Background and Aim Morbidity due to hypertension morbidity is increasing in the Chinese population, and the blood pressure control rate is low. The aim of this trial is to optimize the hypertension treatment plan, promote blood pressure goals and reduce cardio-cerebrovascular events.
Objective and Methods Patients are eligible for inclusion if they are diagnosed with essential hypertension, aged 50-79 years with at least one cardiovascular risk factor and sign the consent forms. This project is a multi-centre, randomized, controlled and blind-endpoint trial. 12 000 patients will be randomly assigned to low-dose Amlodipine and Telmisartan or Amlodipine and diuretics. Patients whose blood cholesterol is between 4.0-6.1mmol/L will also be randomized into small dose of statin-based regimen or standard management regimen; and patients will be randomly assigned to intensive lifestyle intervention group or standard intervention group according to the community area where they live. The primary study outcome is a composite of non-fatal stroke/myocardial infarction and cardiovascular death. Patients will be followed-up for 4 years.
Expected Results The cumulative primary outcome is estimated to be 500 cases, and the hypertension control rate is expected to reach 70%. Cardiovascular events are expected to be reduced by 20% in the optimized treatment group and poor lifestyle will be markedly improved. A total of 150 clinical centres in China will join in the study, which will be completed at the end of 2011.
Citation： WANG Wen,MA Liyuan,ZHANG Yuqing,DENG Qing,LIU Mingbo,LIU Lisheng,for CHIEF Study Group. Rational and Design of Chinese Hypertension Intervention Efficacy Study (CHIEF): A Multi-center, Randomized Controlled Trial of a Combination of Antihypertensive, Lipid Modification and Lifestyle Interventions in Hypertensive Patients (protocol). Chinese Journal of Evidence-Based Medicine, 2007, 07(11): 810-815. doi: Copy