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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Unknown; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01011660

115

Details and patient eligibility

About

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.

Full description

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

Enrollment: 13,542 estimated patients

Sex: All

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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13,542 participants in 4 patient groups

A,1,IV

Active Comparator group

Description:

A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV

Treatment:

Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

A,2,IV

Active Comparator group

Description:

A means active; 2 means Amlodipine+Telmisartan; IV means phase IV

Treatment:

Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

A,3,IV

Active Comparator group

Description:

A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV

Treatment:

Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

A,4,IV

Active Comparator group

Description:

A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV

Treatment:

Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin