drugset / Trial / NCT07652567

Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population

NCT07652567

Completed 690 enrolled Qilu Hospital of Shandong University
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2007-01-01
Primary completion
2026-04-30
Completion
2026-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Indapamide Small molecule 1.5 mg Oral
Subject Telmisartan Other / unclassified 40 mg Oral

Indications