HypertensionBPSCREEN-CRONCT07670741
Community Blood Pressure Screening and Cardiovascular Risk Assessment in Croatia
An observational study of Hypertension and Cardiovascular Risk Factors, run by Dr. Josip Benčević General Hospital at 1 site in Croatia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cardiovascular Risk Factors
- What is being tested?
- Blood pressure measurement and questionnaire-based data collection
- How many people
- 500 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Jul 2026to 15 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18 years or older who voluntarily attend community-based public health blood pressure screening campaigns in Croatia and provide informed consent for participation. Participants may include individuals with or without previously diagnosed hypertension and with or without current antihypertensive treatment. The study population will be recruited from the general adult population attending public health screening activities.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
General Hospital Dr. Josip Bencevic
Slavonski Brod, Brod-Posavina County, 35000
Katica Cvitkušić Lukenda, MD, PhD, +38598556576, kclukenda@gmail.com
kclukenda@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Hypertension, Cardiovascular Risk Factors
- Being tested
- Blood pressure measurement and questionnaire-based data collection
- Keywords
- blood pressure screening, public health campaign, antihypertensive medication
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurement and questionnaire-based data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Community screening participants | Adults attending community-based public health blood pressure screening campaigns who provide informed consent and undergo questionnaire-based data collection and blood pressure measurement. Participants may optionally consent to short-term follow-up by telephone or email 1 to 3 months after the baseline screening visit. Receives: Other: Blood pressure measurement and questionnaire-based data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of elevated blood pressure among adults attending community-based public health screening campaigns
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.
Measured: Baseline screening visit
Secondary outcomes (7)
Proportion of participants with previously known hypertension
Proportion of participants who self-report a previous diagnosis of arterial hypertension.
Measured: Baseline screening visit
Proportion of participants receiving antihypertensive medication
Proportion of participants who report current use of antihypertensive medication.
Measured: Baseline screening visit
Proportion of treated participants with elevated blood pressure at screening
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.
Measured: Baseline screening visit
Distribution of antihypertensive medication classes
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.
Measured: Baseline screening visit
Prevalence of cardiovascular risk factors
Proportion of participants reporting cardiovascular risk factors, including smoking, diabetes mellitus, dyslipidemia, obesity, chronic kidney disease and previous cardiovascular disease.
Measured: Baseline screening visit
Proportion of participants advised to contact a physician
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.
Measured: Baseline screening visit
Follow-up outcomes among participants consenting to short-term follow-up
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.
Measured: 1 to 3 months after baseline screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Josip Benčević General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katica Cvitkusic Lukenda, Dr. Josip Benčević General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670741
- Sponsor's protocol ID
- OBSB-BP-2026-001
- Acronym
- BPSCREEN-CRO
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Aggregated study results may be presented in scientific and professional publications. Data will be stored and processed in accordance with the ethics approval, institutional policies and applicable data protection requirements.