Clinical trial NCT01321242: Achievement of Goal Resting Heart Rate on B-blockers in Patients With Stable Angina and Hypertension
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Hypertension
Keywords: Resting heart rate
Stable Angina
Hypertension
beta-blockers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical practice

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 1 visit within 5 month
Secondary outcomes:
measure: Establish the mean dose of each beta-blocker in patients who achieved and not achieved resting HR goals
timeFrame: 1 visit within 5 month
measure: Compare quality of life in patients who achieved and non achieved resting HR goals
timeFrame: 1 visit within 5 month
measure: To estimate the correlation between achievement of resting HR goals according to ACC/AHA/ACP-ASIM Guidelines for the management of patients
timeFrame: 1 visits within 5 month
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Ulyanovsk
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexey Stepanov
role: STUDY_DIRECTOR
affiliation: The Russian Peoples' Friendship University, Municipal Clinical Hospital #64
name: Z.D. Kobalava
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kobalava Z, Khomitskaya Y, Kiyakbaev G; ATHENA trial investigators. AchievemenT of target resting HEart rate on beta-blockers in patients with stable angiNA and hypertension (ATHENA) in routine clinical practice in Russia. Curr Med Res Opin. 2014 May;30(5):805-11. doi: 10.1185/03007995.2013.874993. Epub 2014 Jan 17.