Arterial Hypertension in Men in the Warmia and Masuria Region

Arterial Hypertension Clinical Trial

— ProM  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03559608
• Other study ID #: ProM
• Status: Active, not recruiting
• Start date: December 1, 2014
• Est. completion date: December 23, 2022

Study information

• Verified date: June 2018
• Source: University of Warmia and Mazury
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• male

Exclusion Criteria:

• female

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Locations

Country	Name	City	State
Poland	University Warmia and Mazury	Olsztyn

Sponsors (2)

Lead Sponsor	Collaborator
University of Warmia and Mazury	Zaklady Farmaceutyczne Polpharma SA / Poland

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. Review. — View Citation

Mancia G, Fagard R, Narkiewicz K, Redón J, Zanchetti A, Böhm 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. — View Citation

Outcome

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

External Links

•   IDF consensus 2006 about Metabolic Syndrome
•   Statistics about life-expectancy-in-europe
•   Statistics about life-expectancy-in-Poland