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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by AstraZeneca

Additional 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
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
Angina, Stable
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 August 18, 2014