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Not yet recruiting NCT07670741

Community Blood Pressure Screening and Cardiovascular Risk Assessment in Croatia

Observational Hypertension Cardiovascular Risk Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood pressure measurement and questionnaire-based data collection.
Who it may be relevant to
Registry conditions: Hypertension, Cardiovascular Risk Factors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Croatia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Observational Study of Blood Pressure Values, Antihypertensive Medication Use and Cardiovascular Risk Factors Among Adults Attending Community-Based Public Health Screening Campaigns in Croatia

Overview

This is a prospective, observational, non-interventional study conducted during community-based public health blood pressure screening campaigns in Croatia. Adult participants who voluntarily attend public health actions will be invited to complete a short questionnaire on demographics, known cardiovascular risk factors, medical history and medication use. Blood pressure and pulse will be measured using validated blood pressure monitors. The study will assess the prevalence of elevated blood pressure, known and potentially undiagnosed hypertension, antihypertensive treatment patterns and cardiovascular risk factors. Participants may optionally consent to short-term follow-up by telephone or e-mail after 1 to 3 months to collect information on repeated blood pressure measurement, physician consultation, additional evaluation, new diagnosis of hypertension or medication change. The study does not include treatment allocation, prescribing or modification of therapy by the research team.

Detailed description

This prospective, observational, non-interventional study will be conducted during community-based public health blood pressure screening campaigns in Croatia. The primary objective is to determine the prevalence of elevated blood pressure among adults attending these screening activities and to describe previously diagnosed hypertension, antihypertensive medication use and associated cardiovascular risk factors.

Adults aged 18 years or older who voluntarily attend the screening activities will be invited to participate. After providing written informed consent, participants will complete a structured questionnaire including demographic characteristics, known cardiovascular risk factors, relevant medical history, current medication use and selected lifestyle factors.

Blood pressure and pulse will be measured in a seated position, after an appropriate resting period, using validated blood pressure monitors and a cuff appropriate for the participant's arm circumference. Three consecutive measurements are planned, with a short interval between measurements. For statistical analysis and classification of blood pressure values, the average of the last two available measurements will be used. If three measurements are available, the average of the second and third measurements will be calculated. If only two measurements are available, the average of the first and second measurements will be used.

Elevated blood pressure and blood pressure values in the hypertension range will be classified according to the prespecified definitions stated in the study protocol. A single elevated blood pressure measurement obtained during a public health screening campaign will not be considered sufficient to establish a diagnosis of arterial hypertension.

The study is non-interventional. The research team will not assign treatment, prescribe medication or modify existing therapy. Participants will receive information about their measured blood pressure values and general advice to repeat blood pressure measurements or contact their family physician or another healthcare professional when indicated by the measured values, reported symptoms or clinical judgment.

Participants who consent to optional short-term follow-up may be contacted by telephone or email 1 to 3 months after the baseline screening visit. Follow-up information will include whether the participant repeated blood pressure measurements, consulted a physician, underwent additional diagnostic evaluation, received a new diagnosis of hypertension or had a change in antihypertensive treatment. Participation in follow-up is voluntary and is not required for participation in the baseline screening component of the study.

Interventions

  • Other Blood pressure measurement and questionnaire-based data collection
    Non-interventional measurement of blood pressure and pulse using validated blood pressure monitors, together with questionnaire-based collection of demographic characteristics, cardiovascular risk factors, medical history, medication use and lifestyle factors. No treatment is assigned, prescribed or modified by the research team.

Primary outcome measures

  • Prevalence of elevated blood pressure among adults attending community-based public health screening campaigns [Time frame: Baseline screening visit]
Secondary outcome measures (7)
  • Proportion of participants with previously known hypertension [Time frame: Baseline screening visit]
  • Proportion of participants receiving antihypertensive medication [Time frame: Baseline screening visit]
  • Proportion of treated participants with elevated blood pressure at screening [Time frame: Baseline screening visit]
  • Distribution of antihypertensive medication classes [Time frame: Baseline screening visit]
  • Prevalence of cardiovascular risk factors [Time frame: Baseline screening visit]
  • Proportion of participants advised to contact a physician [Time frame: Baseline screening visit]
  • Follow-up outcomes among participants consenting to short-term follow-up [Time frame: 1 to 3 months after baseline screening visit]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older
  • Voluntary attendance at a community-based public health blood pressure screening campaign
  • Ability to understand the study information
  • Signed informed consent for participation in the baseline observational study

Exclusion criteria

  • Age under 18 years
  • Inability or unwillingness to provide informed consent
  • Incomplete baseline blood pressure data preventing assessment of the primary outcome
  • Acute medical condition requiring immediate emergency evaluation before completion of study procedures, at the discretion of the research team

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Croatia · 1 center
  • General Hospital Dr. Josip Bencevic — Slavonski Brod

Identifiers

NCT: NCT07670741 · OBSB-BP-2026-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗