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NCT Number: NCT07670741

Community Blood Pressure Screening and Cardiovascular Risk Assessment in Croatia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Dr. Josip Bencevic

Slavonski Brod, Brod-Posavina County, 35000, Croatia

Location contact

Katica Cvitkušić Lukenda, MD, PhD

CONTACT

[email protected]

+38598556576

Katica Cvitkušić Lukenda, MD, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood pressure measurement and questionnaire-based data collection

Other

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 outcomes

  1. Prevalence of elevated blood pressure among adults attending community-based public health screening campaigns

    Time frame: Baseline screening visit

    The proportion of participants with an average systolic blood pressure of 140 millimeters of mercury (mmHg) or higher and/or an average diastolic blood pressure of 90 mmHg or higher at the baseline screening visit. Blood pressure will be calculated as the average of the last two available measurements. If three measurements are obtained, the average of the second and third measurements will be used. If only two measurements are available, the average of the first and second measurements will be used.

Secondary outcomes

  1. Proportion of participants with previously known hypertension

    Time frame: Baseline screening visit

    Proportion of participants who self-report a previous diagnosis of arterial hypertension.

  2. Proportion of participants receiving antihypertensive medication

    Time frame: Baseline screening visit

    Proportion of participants who report current use of antihypertensive medication.

  3. Proportion of treated participants with elevated blood pressure at screening

    Time frame: Baseline screening visit

    Proportion of participants receiving antihypertensive medication who have elevated blood pressure based on the average of the last two available measurements at the baseline screening visit.

  4. Distribution of antihypertensive medication classes

    Time frame: Baseline screening visit

    Distribution of reported antihypertensive medication classes, including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium channel blockers, diuretics, mineralocorticoid receptor antagonists and other antihypertensive medications.

  5. Prevalence of cardiovascular risk factors

    Time frame: Baseline screening visit

    Proportion of participants reporting cardiovascular risk factors, including smoking, diabetes mellitus, dyslipidemia, obesity, chronic kidney disease and previous cardiovascular disease.

  6. Proportion of participants advised to contact a physician

    Time frame: Baseline screening visit

    Proportion of participants advised to contact their family physician or another healthcare professional based on measured blood pressure values, reported symptoms or clinical judgment during the public health screening action.

  7. Follow-up outcomes among participants consenting to short-term follow-up

    Time frame: 1 to 3 months after baseline screening visit

    Among participants who consent to follow-up, the proportion reporting repeated blood pressure measurement, physician consultation, additional diagnostic evaluation, a new diagnosis of hypertension or a change in medication after the baseline screening visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Katica Cvitkušić Lukenda, MD, PhD

CONTACT

[email protected]

+38598556576

Sponsors and collaborators

Lead sponsor

Dr. Josip Benčević General Hospital

Other

Registry information

Official study 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

Acronym: BPSCREEN-CRO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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