NCT03559608

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

3.1 years

First QC Date

April 26, 2018

Last Update Submit

June 5, 2018

Conditions

Arterial Hypertension

Keywords

arterial hypertensionmale healthWarmia-Masuria region

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • male

You may not qualify if:

  • female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Warmia and Mazury

Olsztyn, 10-082, Poland

Location

Related Publications (2)

  • 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.

    PMID: 23817082BACKGROUND

  • 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.

    PMID: 18456100BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood probes and urine probes for laboratory test, frozen samples of serum collected at -80C degree

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Collegium Medicum, Clinical Professor

Study Record Dates

First Submitted

April 26, 2018

First Posted

June 18, 2018

Study Start

December 1, 2014

Primary Completion

December 23, 2017

Study Completion

December 23, 2022

Last Updated

June 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)