Arterial Hypertension in Men in the Warmia and Masuria Region (ProM)

June 5, 2018 updated by: Wojciech Maksymowicz, University of Warmia and Mazury

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Arterial Hypertension

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 Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Poland
- - Olsztyn, Poland, 10-082
    - University Warmia and Mazury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

unselected group of Polish men from the region of Warmia and Mazury

Description

Inclusion Criteria:

male

Exclusion Criteria:

female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	six months after the last inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of metabolic syndrom in male population from Warmia and Masuria region in Poland Time Frame: 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	six months after the last inclusion
Correlation between the parameters measured in blood and arterial blood pressure measurements Time Frame: 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	six months after the last inclusion
The effectiveness of arterial hypertension therapy in men in the region of Warmia an Masuria in Poland Time Frame: six months after the last inclusion	All casual volunteers will provide information about the therapy of hypertension in the questionnaires.	six months after the last inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warmia and Mazury

Collaborators

Zaklady Farmaceutyczne Polpharma SA / Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

December 23, 2017

Study Completion (Anticipated)

December 23, 2022

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)