ProM: Arterial Hypertension in Men in the Warmia and Masuria Region
Study Details
Study Description
Brief 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. 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.
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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
Outcome Measures
Primary Outcome Measures
- The prevalence of arterial hypertension in men in the region Warmia an Masuria in Poland. [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
Secondary Outcome Measures
- The prevalence of metabolic syndrom in male population from Warmia and Masuria region in Poland [six months after the last inclusion]
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
- Correlation between the parameters measured in blood and arterial blood pressure measurements [six months after the last inclusion]
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
- The effectiveness of arterial hypertension therapy in men in the region of Warmia an Masuria in Poland [six months after the last inclusion]
All casual volunteers will provide information about the therapy of hypertension in the questionnaires.
Eligibility Criteria
Criteria
Inclusion Criteria:
- male
Exclusion Criteria:
- female
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Warmia and Mazury | Olsztyn | Poland | 10-082 |
Sponsors and Collaborators
- University of Warmia and Mazury
- Zaklady Farmaceutyczne Polpharma SA / Poland
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Statistics about life-expectancy-in-europe
- Statistics about life-expectancy-in-Poland
- IDF consensus 2006 about Metabolic Syndrome
Publications
- Lawes 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. Review.
- Mancia G, Fagard R, Narkiewicz K, Redón J, Zanchetti A, Böhm 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.
- ProM