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NCT01321242 Clinical Trial

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

Hypertension Clinical Trial

— Athena  

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"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01321242
Other study ID # NIS-CRU-ATC-2011/1
Secondary ID
Status Completed
Phase N/A
First received March 22, 2011
Last updated May 31, 2012
Start date April 2011
Est. completion date August 2011

Study information
Verified date May 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 *American College of Cardiology (ACC)/American Heart Association (AHA)/American College of Physicians (ACP-ASIM) 1 visit within 5 month No
Secondary Establish the mean dose of each beta-blocker in patients who achieved and not achieved resting HR goals 1 visit within 5 month No
Secondary Compare quality of life in patients who achieved and non achieved resting HR goals 1 visit within 5 month No
Secondary To estimate the correlation between achievement of resting HR goals according to ACC/AHA/ACP-ASIM Guidelines for the management of patients 1 visits within 5 month No
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