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Achievement of Goal Resting Heart Rate on B-blockers in Patients With Stable Angina and Hypertension (Athena)

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ClinicalTrials.gov Identifier: NCT01321242
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a multicenter survey of Russian data on target heart rate achievement in patients with stable angina and arterial hypertension who are currently treated with beta-blockers for at least 2 months and with no dose change for a minimum of 4 weeks

Condition or disease
Stable Angina Hypertension

Study Design
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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Non-interventional Study - Epidemiological Survey "AchievemenT of Goal Resting HEart Rate on Beta-blockers in Patients With Stable angiNA and Hypertension in Routine Practice"
Study Start Date : April 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
achieving resting HR goals
Patient population will be comprised of typical for cardiological practice sample of patients with Coronary Heart Disease and arterial hypertension administered beta-blockers, subjects achieving resting HR goals, according to ACC/AHA/ACP-ASIM Guidelines
non-achieving HR goals
Patient population will be comprised of typical for cardiological practice sample of patients with Coronary Heart Disease and arterial hypertension administered beta-blockers, subjects non-achieving HR goals, according to ACC/AHA/ACP-ASIM Guidelines


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Establish the proportion of patients with stable angina and hypertension on beta-blockers reaching the resting HR goals according to ACC/AHA/ACP-ASIM* Guidelines [ Time Frame: 1 visit within 5 month ]
    *American College of Cardiology (ACC)/American Heart Association (AHA)/American College of Physicians (ACP-ASIM)


Secondary Outcome Measures :
  1. Establish the mean dose of each beta-blocker in patients who achieved and not achieved resting HR goals [ Time Frame: 1 visit within 5 month ]
  2. Compare quality of life in patients who achieved and non achieved resting HR goals [ Time Frame: 1 visit within 5 month ]
  3. To estimate the correlation between achievement of resting HR goals according to ACC/AHA/ACP-ASIM Guidelines for the management of patients [ Time Frame: 1 visits within 5 month ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinical practice
Criteria

Inclusion Criteria:

  • Stable angina I-III class by the Canadian Cardiovascular Society Classification and concomitant primary hypertension
  • Subject is on beta-blockers treatment for at least 2 months prior to inclusion into survey, with no dose change for a minimum of 4 weeks

Exclusion Criteria:

  • Use of phenylalkylamine and benzothiazepine calcium channel blockers
  • Hemodynamic significant mitral and aortic valve disease
  • Acute myocardial infarction and unstable angina within 3 months before enrolment
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321242


Locations
Russian Federation
Research Site
Ekaterinburg, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Rostov-on-Don, Russian Federation
Research Site
Saratov, Russian Federation
Research Site
St.Petersburg, Russian Federation
Research Site
Ulyanovsk, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Alexey Stepanov AstraZeneca
Principal Investigator: Z.D. Kobalava The Russian Peoples' Friendship University, Municipal Clinical Hospital #64
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01321242     History of Changes
Other Study ID Numbers: NIS-CRU-ATC-2011/1
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by AstraZeneca:
Resting heart rate
Stable Angina
Hypertension
beta-blockers

Additional relevant MeSH terms:
Hypertension
Angina Pectoris
Angina, Stable
Vascular Diseases
Cardiovascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
 Myocardial Ischemia
Heart Diseases
Signs and Symptoms
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs