Clinical trial NCT03559608: Arterial Hypertension in Men in the Warmia and Masuria Region
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arterial Hypertension
Keywords: arterial hypertension
male health
Warmia-Masuria region
Lead sponsor: University of Warmia and Mazury
Sponsor class: OTHER
Collaborators: name: Zaklady Farmaceutyczne Polpharma SA / Poland
First posted: 2018-06-18
Enrollment: 700
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: unselected group of Polish men from the region of Warmia and Mazury

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.

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.

Eligibility criteria: Inclusion Criteria:

* male

Exclusion Criteria:

* female

Primary outcomes:
measure: The prevalence of arterial hypertension in men in the region Warmia an Masuria in Poland.
timeFrame: six months after the last inclusion
Secondary outcomes:
measure: The prevalence of metabolic syndrom in male population from Warmia and Masuria region in Poland
timeFrame: six months after the last inclusion
measure: Correlation between the parameters measured in blood and arterial blood pressure measurements
timeFrame: six months after the last inclusion
measure: The effectiveness of arterial hypertension therapy in men in the region of Warmia an Masuria in Poland
timeFrame: six months after the last inclusion
Other outcomes:
Locations:
city: Olsztyn
country: Poland
facility: University Warmia and Mazury
Study officials:
References:
citation: 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.
citation: 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.