General Hospital Dr. Josip Bencevic
Slavonski Brod, Brod-Posavina County, 35000, Croatia
Location contact
Katica Cvitkušić Lukenda, MD, PhD
CONTACT
Katica Cvitkušić Lukenda, MD, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07670741
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Slavonski Brod, Brod-Posavina County, 35000, Croatia
Katica Cvitkušić Lukenda, MD, PhD
CONTACT
Katica Cvitkušić Lukenda, MD, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline screening visit
Proportion of participants who self-report a previous diagnosis of arterial hypertension.
Time frame: Baseline screening visit
Proportion of participants who report current use of antihypertensive medication.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Dr. Josip Benčević General Hospital
Other
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
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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