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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2012 by Ma Liyuan, Cardiovascular Institute & Fuwai Hospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Ma Liyuan, Cardiovascular Institute & Fuwai Hospital

ClinicalTrials.gov Identifier:

NCT01011660

First received: November 10, 2009

Last updated: August 9, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2009

Last Updated Date

August 9, 2012

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01011660 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: 3-4 years ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Essential Hypertension

Intervention ^ICMJE

Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

Amlodipine; Telmisartan; Amiloride Compound; Simvastatin

Other Name: CHIEF

Study Arms

Active Comparator: A,1,IV
A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV

Intervention: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Active Comparator: A,2,IV
A means active; 2 means Amlodipine+Telmisartan; IV means phase IV

Intervention: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Active Comparator: A,3,IV
A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV

Intervention: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Active Comparator: A,4,IV
A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV

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

Publications *

Ma L, Wang W, Zhao Y, Zhang Y, Deng Q, Liu M, Sun H, Wang J, Liu L. Combination of amlodipine plus angiotensin receptor blocker or diuretics in high-risk hypertensive patients: a 96-week efficacy and safety study. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):137-42. doi: 10.2165/11598110-000000000-00000.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

13542

Estimated Completion Date

December 2012

Estimated Primary Completion Date

August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years to 79 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01011660

Other Study ID Numbers ^ICMJE

115

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Ma Liyuan, Cardiovascular Institute & Fuwai Hospital

Study Sponsor ^ICMJE

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Wen Wang, Professor

Chinese Academy of Medical Sciences

PRS Account

Chinese Academy of Medical Sciences, Fuwai Hospital

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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