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

This study is currently recruiting participants.
Verified August 2012 by Cardiovascular Institute & Fuwai Hospital
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

November 10, 2009
August 9, 2012
October 2007
August 2012   (final data collection date for primary outcome measure)
The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death. [ Time Frame: 3-4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01011660 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients
Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Essential Hypertension
Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
Other Name: CHIEF
  • 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
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.
 
Recruiting
13542
December 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 79 Years
No
Not Provided
China
 
NCT01011660
115
Yes
Ma Liyuan, Cardiovascular Institute & Fuwai Hospital
Cardiovascular Institute & Fuwai Hospital
Not Provided
Principal Investigator: Wen Wang, Professor Chinese Academy of Medical Sciences
Cardiovascular Institute & Fuwai Hospital
August 2012

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