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

May 31, 2012 updated by: AstraZeneca

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"

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 visit within 5 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 visit within 5 month
Compare quality of life in patients who achieved and non achieved resting HR goals
Time Frame: 1 visit within 5 month
1 visit within 5 month
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
1 visits within 5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Z.D. Kobalava, The Russian Peoples' Friendship University, Municipal Clinical Hospital #64

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimate)

March 23, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CRU-ATC-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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