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Clinical Trials/NCT03559608
NCT03559608
Unknown
Not Applicable

Program for the Detection of Hypertension, Its Complications and Factors Predisposing to the Development of Hypertension in Men in the Warmia and Masuria Region

University of Warmia and Mazury1 site in 1 country700 target enrollmentDecember 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arterial Hypertension
Sponsor
University of Warmia and Mazury
Enrollment
700
Locations
1
Primary Endpoint
The prevalence of arterial hypertension in men in the region Warmia an Masuria in Poland.
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2014
End Date
December 23, 2022
Last Updated
7 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
University of Warmia and Mazury
Responsible Party
Principal Investigator
Principal Investigator

Wojciech Maksymowicz

Head of Collegium Medicum, Clinical Professor

University of Warmia and Mazury

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The prevalence of metabolic syndrom in male population from Warmia and Masuria region in Poland(six months after the last inclusion)
  • Correlation between the parameters measured in blood and arterial blood pressure measurements(six months after the last inclusion)
  • The effectiveness of arterial hypertension therapy in men in the region of Warmia an Masuria in Poland(six months after the last inclusion)

Study Sites (1)

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