Arterial HypertensionProMNCT03559608
Arterial Hypertension in Men in the Warmia and Masuria Region
An observational study of Arterial Hypertension, run by University of Warmia and Mazury at 1 site in Poland.
Trial summary
The primary aim of the study is to define the prevalence of arterial hypertension and risk factors of its development in an unselected group of Polish men from the region of Warmia and Mazury, considered as one of the most unprivileged in terms of social and employment status in Poland. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Arterial Hypertension
- How many people
- 700 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2014to 23 Dec 2022
- How long will I take part?
- 5 Years
- 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 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: unselected group of Polish men from the region of Warmia and Mazury
Who may be able to join
- male
Who cannot join
- female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Program for the Detection of Hypertension, Its Complications and Factors Predisposing to the Development of Hypertension in Men in the Warmia and Masuria Region
The primary aim of the study is to define the prevalence of arterial hypertension and risk factors of its development in an unselected group of Polish men from the region of Warmia and Mazury, considered as one of the most unprivileged in terms of social and employment status in Poland. Polish men life expectancy at birth is 74 years and is lower as polish women life expectancy at birth by 8 years. The difference in Western Europe is 5 years. ProM aims to investigate the prevalence of arterial hypertension as well as to increase the interest in its prevention and treatment in men from the region.
Read the detailed description
Increased arterial blood pressure (HT) in chronic conditions is a major risk factor of cardiovascular morbidity and premature mortality. HT is diagnosed in 30-45% of global adult population and this number is still growing. The primary aim of the study is to define the prevalence of arterial hypertension and risk factors of its development in an unselected group of Polish men from the region of Warmia and Mazury, considered as one of the most unprivileged in terms of social and employment status in Poland. Polish men life expectancy at birth is 74 years and is lower as polish women life expectancy at birth by 8 years. The difference in Western Europe is 5 years (79 male vs. 84 female) (https://www.statista.com/statistics/274514/life-expectancy-in-europe/).
The study protocol is approved by the Ethics Committee of the Regional Medical Chamber of Warmia and Mazury in Poland. The study are conducted according to the Good Clinical Practice guidelines. Each participant signs an informed consent and be coded with unique ID. As a pivotal part of the ProM project, arterial blood pressure have to be measured in agreement with the ESH/ESC guidelines in randomly selected male subjects. Participants will complete coded and standardized questionnaire and received a referral for free blood and urine tests.
In serum will be tested: glucose, creatinine and lipid profile; microalbuminuria and creatinine were measured in urine, urinary albumin-to-creatinine ratio (UACR) will be calculated. Estimated glomerular filtration rate (eGFR) will be calculated according to the MDRD formula. 1-2 ml of serum will be frozen at -80C degree.
Results of analyses will be saved by indexing with ID code only, personal data with individual IDs will be saved in additional file. All hard copy will be archived in secure room with coded electronic key.
The investigators plan to repeat the measurements in 5 years in follow-up study.
ProM aims to investigate the prevalence of arterial hypertension as well as to increase the interest in its prevention and treatment in men from the region.
- Conditions
- Arterial Hypertension
- Keywords
- arterial hypertension, male health, Warmia-Masuria region
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of arterial hypertension in men in the region Warmia an Masuria in Poland.
For every casual adult male volunteer the arterial blood pressure will be measured in companies, the University, rural areas, stores and markets. Arterial hypertension will be diagnosed in agree with Guidelines ESH/ESC 2013
Measured: six months after the last inclusion
Secondary outcomes (3)
The prevalence of metabolic syndrom in male population from Warmia and Masuria region in Poland
Metabolic syndrome will be diagnosed in participants who will fulfill the criteria of defined by The International Diabetes Federation (2006) and who will participate in free blood tests, waist circumference and blood pressure measurements
Measured: six months after the last inclusion
Correlation between the parameters measured in blood and arterial blood pressure measurements
Sources for the blood parameters will be blood sera collected and frozed at -80C degree from all participants who will participate in free blood tests and blood pressure measurements
Measured: six months after the last inclusion
The effectiveness of arterial hypertension therapy in men in the region of Warmia an Masuria in Poland
All casual volunteers will provide information about the therapy of hypertension in the questionnaires.
Measured: six months after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Dec 2014
- Primary completion23 Dec 2017
- Study completion23 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arterial 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
- Prospective
- Enrolment
- 700 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury
- Sponsor type
- University, hospital or other
- Collaborators
- Zaklady Farmaceutyczne Polpharma SA / Poland
- Responsible party
- Principal investigator, Wojciech Maksymowicz, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559608
- Sponsor's protocol ID
- ProM
- Acronym
- ProM
- Status last verified
- Jun 2018
- First submitted
- 26 Apr 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
PubMed 23817082Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure-related disease, 2001. Lancet. 2008 May 3;371(9623):1513-8. doi: 10.1016/S0140-6736(08)60655-8.
PubMed 18456100
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program for the Detection of Hypertension, Its Complications and Factors Predisposing to the Development of Hypertension in Men in the Warmia and Masuria Region
- ClinicalTrials.gov ID
- NCT03559608
- Acronym / sponsor ID
- ProM / ProM
- Conditions
- Arterial Hypertension
- Keywords
- arterial hypertension, male health, Warmia-Masuria region
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of Warmia and MazuryUniversity, hospital or other
- Collaborators
- Zaklady Farmaceutyczne Polpharma SA / Poland
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 23 Dec 2022 (estimated)
- First posted
- 18 Jun 2018 (actual)
- 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 primary aim of the study is to define the prevalence of arterial hypertension and risk factors of its development in an unselected group of Polish men from the region of Warmia and Mazury, considered as one of the most unprivileged in terms of social and employment status in Poland. Polish men life expectancy at birth is 74 years and is lower as polish women life expectancy at birth by 8 years. The difference in Western Europe is 5 years. ProM aims to investigate the prevalence of arterial hypertension as well as to increase the interest in its prevention and treatment in men from the region.
Detailed description
Increased arterial blood pressure (HT) in chronic conditions is a major risk factor of cardiovascular morbidity and premature mortality. HT is diagnosed in 30-45% of global adult population and this number is still growing. The primary aim of the study is to define the prevalence of arterial hypertension and risk factors of its development in an unselected group of Polish men from the region of Warmia and Mazury, considered as one of the most unprivileged in terms of social and employment status in Poland. Polish men life expectancy at birth is 74 years and is lower as polish women life expectancy at birth by 8 years. The difference in Western Europe is 5 years (79 male vs. 84 female) (https://www.statista.com/statistics/274514/life-expectancy-in-europe/).
The study protocol is approved by the Ethics Committee of the Regional Medical Chamber of Warmia and Mazury in Poland. The study are conducted according to the Good Clinical Practice guidelines. Each participant signs an informed consent and be coded with unique ID. As a pivotal part of the ProM project, arterial blood pressure have to be measured in agreement with the ESH/ESC guidelines in randomly selected male subjects. Participants will complete coded and standardized questionnaire and received a referral for free blood and urine tests.
In serum will be tested: glucose, creatinine and lipid profile; microalbuminuria and creatinine were measured in urine, urinary albumin-to-creatinine ratio (UACR) will be calculated. Estimated glomerular filtration rate (eGFR) will be calculated according to the MDRD formula. 1-2 ml of serum will be frozen at -80C degree.
Results of analyses will be saved by indexing with ID code only, personal data with individual IDs will be saved in additional file. All hard copy will be archived in secure room with coded electronic key.
The investigators plan to repeat the measurements in 5 years in follow-up study.
ProM aims to investigate the prevalence of arterial hypertension as well as to increase the interest in its prevention and treatment in men from the region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- unselected group of Polish men from the region of Warmia and Mazury
Key inclusion criteria (1 listed)
- male
Key exclusion criteria (1 listed)
- female
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
The prevalence of arterial hypertension in men in the region Warmia an Masuria in Poland.
Time frame: six months after the last inclusion
For every casual adult male volunteer the arterial blood pressure will be measured in companies, the University, rural areas, stores and markets. Arterial hypertension will be diagnosed in agree with Guidelines ESH/ESC 2013
3 secondary outcomes
The prevalence of metabolic syndrom in male population from Warmia and Masuria region in Poland
Time frame: six months after the last inclusion
Correlation between the parameters measured in blood and arterial blood pressure measurements
Time frame: six months after the last inclusion
The effectiveness of arterial hypertension therapy in men in the region of Warmia an Masuria in Poland
Time frame: six months after the last inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Background: PubMed 23817082Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
- Background: PubMed 18456100Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure-related disease, 2001. Lancet. 2008 May 3;371(9623):1513-8. doi: 10.1016/S0140-6736(08)60655-8.
- Statistics about life-expectancy-in-europeLink provided by the sponsor.
- Statistics about life-expectancy-in-PolandLink provided by the sponsor.
- IDF consensus 2006 about Metabolic SyndromeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, run by University of Warmia and Mazury at 1 site in Poland.
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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
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?
The prevalence of arterial hypertension in men in the region Warmia an Masuria in Poland. (time frame: six months after the last inclusion). 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 NCT03559608, which also lists 2 linked publications.
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 18 Jun 2018.