University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
Location status: Recruiting
NCT Number: NCT07482462
The goal of this observational study is to assess arterial stiffness and autonomic regulation of blood pressure and heart rate in healthy adults and people with arterial hypertension during orthostatic stress and graded physical exercise. The main objective is to analyze cardiovascular responses to exercise on a cycle ergometer in different subgroups of participants with hypertension.
The study includes healthy young adults and older adults with hypertension. Participants undergo standardized assessments including orthostatic testing, graded exercise testing on a cycle ergometer, electrocardiography, and measurement of arterial stiffness parameters such as pulse wave velocity, as well as other vascular and hemodynamic parameters.
The results of this study are expected to improve understanding of cardiovascular physiology and autonomic regulation in people with hypertension and may contribute to earlier recognition of autonomic dysfunction and improved clinical management.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ljubljana, 1000, Slovenia
Location status: Recruiting
The autonomic nervous system plays an important role in the regulation of cardiovascular responses to orthostatic stress and physical exercise. Alterations in autonomic regulation may contribute to abnormal blood pressure responses, orthostatic hypotension, or exaggerated blood pressure responses during exercise, particularly in individuals with arterial hypertension.
The aim of this study is to assess arterial stiffness and autonomic regulation of blood pressure and heart rate in healthy individuals and people with arterial hypertension. The study includes healthy young adults and older adults with hypertension who are followed at the Department of Hypertension. Older participants are further categorized into subgroups including hypertension, hypertension with orthostatic hypotension, hypertension with orthostatic hypertension, and hypertension with diabetes mellitus.
All participants undergo standardized cardiovascular evaluation including orthostatic testing, graded exercise testing on a cycle ergometer, electrocardiography, and measurement of arterial stiffness parameters such as pulse wave velocity. During these procedures, blood pressure responses, heart rate variability, and heart rate recovery after exercise are assessed. Additional vascular and hemodynamic parameters are also recorded.
Additional clinical data, including laboratory test results and ambulatory blood pressure monitoring (ABPM) obtained as part of routine outpatient care prior to study participation, are collected from medical records for participants with hypertension with their written informed consent.
The study aims to improve understanding of cardiovascular autonomic regulation and vascular function in both healthy individuals and people with hypertension and related conditions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (Day 1 study visit)
Assessment of heart rate variability parameters during orthostatic testing and graded exercise testing as indicators of autonomic cardiovascular regulation.
Time frame: During graded exercise testing at the study visit (Day 1)
Assessment of systolic and diastolic blood pressure response during graded exercise testing on a cycle ergometer.
Time frame: Baseline (Day 1 study visit)
Measurement of arterial stiffness using pulse wave velocity.
Time frame: Immediately after graded exercise testing at the study visit (Day 1)
Rate of decrease in heart rate following completion of graded exercise testing on a cycle ergometer.
Time frame: During orthostatic testing at the study visit (Day 1)
Assessment of changes in systolic and diastolic blood pressure during standardized orthostatic testing.
Time frame: During orthostatic testing at the study visit (Day 1)
Change in heart rate during standardized orthostatic testing.
Contact information is provided by the study sponsor or research team.
University Medical Centre Ljubljana
Other
Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise
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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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