Stable AnginaAthenaNCT01321242
Achievement of Goal Resting Heart Rate on B-blockers in Patients With Stable Angina and Hypertension
An observational study of Stable Angina and Hypertension, run by AstraZeneca at 6 sites in Russia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Hypertension
- How many people
- 400 participants
- Where
- 6 sitesRussia
- Study dates
- Apr 2011to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical practice
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Research Site
Moscow
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Saratov
Research Site
Ulyanovsk
Research Site
Yekaterinburg
About this study
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"
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
- Conditions
- Stable Angina, Hypertension
- Keywords
- Resting heart rate, Stable Angina, Hypertension, beta-blockers
- Medical subject headings
- Angina, Stable, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 visit within 5 month
Secondary outcomes (3)
Establish the mean dose of each beta-blocker in patients who achieved and not achieved resting HR goals
Measured: 1 visit within 5 month
Compare quality of life in patients who achieved and non achieved resting HR goals
Measured: 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
Measured: 1 visits within 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Stepanov, Study director, AstraZenecaZ.D. Kobalava, Principal investigator, The Russian Peoples' Friendship University, Municipal Clinical Hospital #64
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321242
- Sponsor's protocol ID
- NIS-CRU-ATC-2011/1
- Acronym
- Athena
- Status last verified
- May 2012
- First submitted
- 22 Mar 2011
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24400847
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT01321242
- Acronym / sponsor ID
- Athena / NIS-CRU-ATC-2011/1
- Conditions
- Stable Angina, Hypertension
- Keywords
- Resting heart rate, Stable Angina, Hypertension, beta-blockers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical practice
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
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
Compare quality of life in patients who achieved and non achieved resting HR goals
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
- Derived from this study: PubMed 24400847Kobalava 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Stepanov study director
AstraZeneca
Z.D. Kobalava principal investigator
The Russian Peoples' Friendship University, Municipal Clinical Hospital #64
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina and Hypertension, run by AstraZeneca at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 visit within 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.