I. Research Objectives Primary Objectives: To evaluate the effect of low-dose antihypertensive therapy on the incidence of new-onset hypertension and new-onset diabetes in individuals with high-normal blood pressure and cardiovascular risk factors. To assess the impact of low-dose antihypertensive therapy on composite cardiovascular events in individuals with high-normal blood pressure and cardiovascular risk factors. Secondary Objective: To evaluate the effects of low-dose antihypertensive therapy and different drug regimens on intermediate markers or subclinical status of cardiovascular disease risk, including lipid profiles, carotid atherosclerosis, and arterial stiffness (pulse wave velocity). II. Study Population Individuals with high-normal blood pressure and comorbid cardiovascular risk factors who have not been treated with antihypertensive medications. III. Endpoints Primary Endpoints: New-onset hypertension and new-onset diabetes. Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization). Other Endpoints: Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
690
Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.
Patients will receive a placebo, administered as half a tablet once daily.
Qilu Hospital of Shandong University
Jinan, Shandong, China
1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).
1. New-onset hypertension Incidence of new-onset hypertension during follow-up. Unit of Measure: Number and percentage of participants. 2. New-onset diabetes Incidence of new-onset diabetes during follow-up. Unit of Measure: Number and percentage of participants. 3. Composite cardiovascular events Incidence of composite cardiovascular events during follow-up, defined as the occurrence of at least one of the following: fatal or non-fatal stroke, myocardial infarction, cardiovascular death, or coronary revascularization. Participants with multiple events will be counted once for the composite endpoint. Unit of Measure: Number and percentage of participants.
Time frame: through study completion, an average of 4 year
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