Arterial Hypertension in Men in the Warmia and Masuria Region

NCT ID: NCT03559608

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-01

Study Completion Date

2022-12-23

Brief Summary

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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

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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

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Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* male

Exclusion Criteria

* female
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zaklady Farmaceutyczne Polpharma SA / Poland

UNKNOWN

Sponsor Role collaborator

University of Warmia and Mazury

OTHER

Sponsor Role lead

Responsible Party

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Wojciech Maksymowicz

Head of Collegium Medicum, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Warmia and Mazury

Olsztyn, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 23817082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18456100 (View on PubMed)

Related Links

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Other Identifiers

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ProM

Identifier Type: -

Identifier Source: org_study_id

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