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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
History of Changes
  Purpose

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 Intervention Phase
Essential Hypertension
 Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • 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 ]

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 [ Time Frame: 3-4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 13542
Study Start Date: October 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: CHIEF

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011660

Locations
China, Beijing
Wang Wen Recruiting
Beijing, Beijing, China, 100037
Contact: Liyuan Ma     86 10 68335002     maliyuan600@vip.sina.com    
Principal Investigator: Wen Wang            
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Investigators
Principal Investigator: Wen Wang, Professor Chinese Academy of Medical Sciences
  More Information

No publications provided by Cardiovascular Institute & Fuwai Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ma Liyuan, Dr, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01011660     History of Changes
Other Study ID Numbers: 115
Study First Received: November 10, 2009
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
hypertension
cardiovascular risk factors
drugs intervention
lipid-lowering therapy
50-79 years of age
 sign
the informed
consent
forms

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amiloride
Diuretics
Amlodipine
Simvastatin
Telmisartan
Angiotensin Receptor Antagonists
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
 Natriuretic Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Vasodilator Agents
Antihypertensive Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013