Arterial Hypertension in Men in the Warmia and Masuria Region
NCT ID: NCT03559608
Last Updated: 2018-06-18
Study Results
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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UNKNOWN
700 participants
OBSERVATIONAL
2014-12-01
2022-12-23
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
MALE
Yes
Sponsors
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Zaklady Farmaceutyczne Polpharma SA / Poland
UNKNOWN
University of Warmia and Mazury
OTHER
Responsible Party
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Wojciech Maksymowicz
Head of Collegium Medicum, Clinical Professor
Locations
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University Warmia and Mazury
Olsztyn, , Poland
Countries
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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.
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.
Related Links
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Statistics about life-expectancy-in-europe
Statistics about life-expectancy-in-Poland
IDF consensus 2006 about Metabolic Syndrome
Other Identifiers
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ProM
Identifier Type: -
Identifier Source: org_study_id
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