Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients

Study Overview
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Brief Summary
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The aim of the study is to investigate the optimized treatment strategy of hypertension, so as to make more patients to reach the blood pressure goals and to reduce cardio-cerebrovascular events. Objective and Methods: Patients are eligible for inclusion in the study if they are essential hypertension, 50-79 years of age with at least one cardiovascular risk factor and sign the informed consent forms. This project is a multi-centre, prospective randomized,，openlabel blind-endpoint evaluation controlled (PROBE) trial. 12000 patients will be randomly assigned to either of low-dose Amlodipine+Telmisartan group or Amlodipine+ diuretics group. Among those patients with serum cholesterol between 4.0-6.1mmol/L, they will be also randomized into small dose of statin-based regimen or standard management regimen; Patients will also randomly assigned to intensive lifestyle intervention group or standard intervention group according to the community area where the patients in.

Detailed Description
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This study is aimed to observe the main outcome (stroke, myocardial infarction and death from cardiovascular disease) differences between different groups.

Official Title
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Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: essential hypertension 50-79 years old with at least one of the cardiovascular risk factor sign consent forms Exclusion Criteria: secondary hypertension attack of cerebrovascular events or myocardial infarction within recent 3 months coexistence of severe cardiomyopathy, rheumatic or congenital heart diseases unstable angina severe hepatopathy or nephropathy (ALT elevation > 2 fold or serum creatinine > 2.5mg/dl) malignant tumor gout women taking contraceptives or with pregnancy allergic history to the research drugs validated contradiction to the research drugs participating in other clinical trials unable for long-term follow-up or poor compliance unsuitable for clinical trial at the discretion of doctors in charge

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A,1,IV<br>A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV | Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin<br>* Amlodipine; Telmisartan; Amiloride Compound; Simvastatin<br>* Other names: CHIEF;|
| Active Comparator: A,2,IV<br>A means active; 2 means Amlodipine+Telmisartan; IV means phase IV | Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin<br>* Amlodipine; Telmisartan; Amiloride Compound; Simvastatin<br>* Other names: CHIEF;|
| Active Comparator: A,3,IV<br>A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV | Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin<br>* Amlodipine; Telmisartan; Amiloride Compound; Simvastatin<br>* Other names: CHIEF;|
| Active Comparator: A,4,IV<br>A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV | Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin<br>* Amlodipine; Telmisartan; Amiloride Compound; Simvastatin<br>* Other names: CHIEF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death. |  | 3-4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cardiovascular events；all-cause death, hospitalization for angina pectoris, coronary revascularization, aortic dissection, cerebrovascular disease, heart failure, renal insufficiency, tumor, new onset of atrial fibrillation and diabetes mellitus |  | 3-4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, cardiovascular risk factors, drugs intervention, lipid-lowering therapy, 50-79 years of age, sign, the informed, consent, forms