HypertensionESSE-RFNCT02449460
Cardiovascular Epidemiology in Russian Federation
An observational study of Hypertension and Coronary Artery Disease, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 2 sites in Russia.
Trial summary
The study addresses epidemiology of cardiovascular risk factors and major cardiovascular diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants in each will be included. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Coronary Artery Disease, Diabetes
- How many people
- 18,000 participants
- Where
- 2 sitesRussia
- Study dates
- Jul 2012to Dec 2022
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Random sample population
Who may be able to join
- informed consent
Who cannot join
- No
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Orenburg Medical Academi
Orenburg
Roman Libis, Prof, 79111555524, libis@mail.ru
Roman Libis, Prof
- Recruiting
Samara Medical University
Samara
Dmitry Duplyakov, 79277297273, dyplyakov@yahoo.com
Dmitriy Duplyakov, prof
About this study
Official title: Multicenter Observational Study of Epidemiology of Cardiovascular Diseases and Risk Factors in Different Regions of Russian Federation
The study addresses epidemiology of cardiovascular risk factors and major cardiovascular diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants in each will be included.
Read the detailed description
Plasma lipids and fasting glucose, heart rate and blood pressure, anthropometry, smoking and alcohol questionaries, nutrition, sleep quality, stress will be assessed. ECG records are obtained form all participants. Subclinical target organ damage (carotid and periferal atherosclerosis, pulse wave velocity) will be measured in selected sites. Brain natriuretic peptide, adipose tissue cytokines, hsCRP and genetic markers are also under evaluation
- Conditions
- Hypertension, Coronary Artery Disease, Diabetes, Heart Failure, Smoking, Lifestyle
- Keywords
- hypertension, epidemiology, glucose, body mass index, lipids, smoking, coronary artery disease, arterial stiffness, carotid ultrasound
- Medical subject headings
- Hypertension, Coronary Artery Disease, Diabetes Mellitus, Heart Failure, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
all cause motality registered by official statistics
Measured: 10 years
Secondary outcomes (3)
Stroke
ischemic and heamorragic stroke
Measured: 10 years
Miocardial infarction
Measured: 10 years
Cardiovascular mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJul 2012
- Primary completionMar 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Center for Preventive Medicine, Russian Cardiology Research and Production Center
- Responsible party
- Principal investigator, Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Investigators
- Svetlana A Shalnova, Prof, Study chair, State Sientific Center of Preventive MedicineAlexandra O Konradi, Prof, Principal investigator, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthEugene I Chazov, Prof, Principal investigator, Russian Research and Production Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449460
- Sponsor's protocol ID
- AlmazovFCHBE-4
- Acronym
- ESSE-RF
- Status last verified
- Jul 2016
- First submitted
- 18 May 2015
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study of Epidemiology of Cardiovascular Diseases and Risk Factors in Different Regions of Russian Federation
- ClinicalTrials.gov ID
- NCT02449460
- Acronym / sponsor ID
- ESSE-RF / AlmazovFCHBE-4
- Conditions
- Hypertension, Coronary Artery Disease, Diabetes, Heart Failure, Smoking, Lifestyle
- Keywords
- hypertension, epidemiology, glucose, body mass index, lipids, smoking, coronary artery disease, arterial stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Collaborators
- National Research Center for Preventive Medicine, Russian Cardiology Research and Production Center
- Study start
- Jul 2012
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 May 2015 (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.
The study addresses epidemiology of cardiovascular risk factors and major cardiovascular diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants in each will be included.
Detailed description
Plasma lipids and fasting glucose, heart rate and blood pressure, anthropometry, smoking and alcohol questionaries, nutrition, sleep quality, stress will be assessed. ECG records are obtained form all participants. Subclinical target organ damage (carotid and periferal atherosclerosis, pulse wave velocity) will be measured in selected sites. Brain natriuretic peptide, adipose tissue cytokines, hsCRP and genetic markers are also under evaluation
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Random sample population
Key inclusion criteria (1 listed)
- informed consent
Key exclusion criteria (1 listed)
- No
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
all cause mortality
Time frame: 10 years
all cause motality registered by official statistics
3 secondary outcomes
Stroke
Time frame: 10 years
Miocardial infarction
Time frame: 10 years
Cardiovascular mortality
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
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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.
Svetlana A Shalnova, Prof study chair
State Sientific Center of Preventive Medicine
Alexandra O Konradi, Prof principal investigator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Eugene I Chazov, Prof principal investigator
Russian Research and Production Complex
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Coronary Artery Disease, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 2 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugene V Shlyakhto, Prof (78127023700, e.shlyakhto@almazovcentre.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2016.