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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01011660

Collaborator

(none)

13,542

Enrollment

Location

Arms

Duration (Months)

218.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

13542 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2007

Anticipated Primary Completion Date :

Aug 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A,1,IV A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV	Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin Amlodipine; Telmisartan; Amiloride Compound; Simvastatin Other Names: CHIEF
Active Comparator: A,2,IV A means active; 2 means Amlodipine+Telmisartan; IV means phase IV	Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin Amlodipine; Telmisartan; Amiloride Compound; Simvastatin Other Names: CHIEF
Active Comparator: A,3,IV A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV	Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin Amlodipine; Telmisartan; Amiloride Compound; Simvastatin Other Names: CHIEF
Active Comparator: A,4,IV A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV	Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin Amlodipine; Telmisartan; Amiloride Compound; Simvastatin Other Names: CHIEF

Outcome Measures

Primary Outcome Measures

The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death. [3-4 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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