Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients (CHIEF)
Primary Purpose
Essential Hypertension
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring hypertension, cardiovascular risk factors, drugs intervention, lipid-lowering therapy, 50-79 years of age, sign, the informed, consent, forms
Eligibility Criteria
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
Sites / Locations
- Wang WenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
A,1,IV
A,2,IV
A,3,IV
A,4,IV
Arm Description
A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV
A means active; 2 means Amlodipine+Telmisartan; IV means phase IV
A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV
A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV
Outcomes
Primary Outcome Measures
The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.
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
Full Information
NCT ID
NCT01011660
First Posted
November 10, 2009
Last Updated
August 9, 2012
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01011660
Brief Title
Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients
Acronym
CHIEF
Official Title
Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
This study is aimed to observe the main outcome (stroke, myocardial infarction and death from cardiovascular disease) differences between different groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
hypertension, cardiovascular risk factors, drugs intervention, lipid-lowering therapy, 50-79 years of age, sign, the informed, consent, forms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13542 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A,1,IV
Arm Type
Active Comparator
Arm Description
A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV
Arm Title
A,2,IV
Arm Type
Active Comparator
Arm Description
A means active; 2 means Amlodipine+Telmisartan; IV means phase IV
Arm Title
A,3,IV
Arm Type
Active Comparator
Arm Description
A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV
Arm Title
A,4,IV
Arm Type
Active Comparator
Arm Description
A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV
Intervention Type
Drug
Intervention Name(s)
Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Other Intervention Name(s)
CHIEF
Intervention Description
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
Primary Outcome Measure Information:
Title
The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.
Time Frame
3-4 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Wang, Professor
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wang Wen
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyuan Ma
Phone
86 10 68335002
Email
maliyuan600@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Wen Wang
12. IPD Sharing Statement
Citations:
PubMed Identifier
22329591
Citation
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.
Results Reference
derived
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Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients
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