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Trial record 1 of 1 for:    NIS-CRU-ATC-2011/1
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Achievement of Goal Resting Heart Rate on B-blockers in Patients With Stable Angina and Hypertension (Athena)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01321242
First received: March 22, 2011
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Stable Angina
Hypertension

Study Type: Observational
Study Design: 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"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    *American College of Cardiology (ACC)/American Heart Association (AHA)/American College of Physicians (ACP-ASIM)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Compare quality of life in patients who achieved and non achieved resting HR goals [ Time Frame: 1 visit within 5 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01321242     History of Changes
Other Study ID Numbers: NIS-CRU-ATC-2011/1
Study First Received: March 22, 2011
Last Updated: May 31, 2012
Health Authority: Russia: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013