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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Young Adults | Healthy volunteers aged 18-35 years without known cardiovascular disease. | ||
| Hypertension | Participants with arterial hypertension without orthostatic blood pressure abnormalities during orthostatic testing and without diabetes. | ||
| Hypertension With Orthostatic Hypotension | Participants with arterial hypertension and orthostatic hypotension identified during orthostatic testing. | ||
| Hypertension With Diabetes | Participants with arterial hypertension and coexisting diabetes. | ||
| Hypertension With Orthostatic Hypertension | Participants with arterial hypertension and orthostatic hypertension identified during orthostatic testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | Assessment of heart rate variability parameters during orthostatic testing and graded exercise testing as indicators of autonomic cardiovascular regulation. | Baseline (Day 1 study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Response to Exercise | Assessment of systolic and diastolic blood pressure response during graded exercise testing on a cycle ergometer. | During graded exercise testing at the study visit (Day 1) |
| Pulse Wave Velocity |
| Measure | Description | Time Frame |
|---|---|---|
| Orthostatic Blood Pressure Response | Assessment of changes in systolic and diastolic blood pressure during standardized orthostatic testing. | During orthostatic testing at the study visit (Day 1) |
| Orthostatic Heart Rate Response |
Inclusion Criteria:
Exclusion Criteria:
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The study population includes healthy young adults and older adults with arterial hypertension who are followed at the Department of Hypertension, University Medical Centre Ljubljana. Participants with hypertension are categorized into subgroups including hypertension without orthostatic blood pressure abnormalities, hypertension with orthostatic hypotension, hypertension with orthostatic hypertension, and hypertension with diabetes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amela Kabaklić, MD, PhD | Contact | +386 1 522 43 05 | amela.kabaklic@kclj.si |
| Name | Affiliation | Role |
|---|---|---|
| Amela Kabaklić, MD, PhD | University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24237859 | Background | Pecanha T, Silva-Junior ND, Forjaz CL. Heart rate recovery: autonomic determinants, methods of assessment and association with mortality and cardiovascular diseases. Clin Physiol Funct Imaging. 2014 Sep;34(5):327-39. doi: 10.1111/cpf.12102. Epub 2013 Nov 17. | |
| 29034226 | Background | Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017. |
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Individual participant data will not be shared due to privacy and confidentiality considerations related to clinical data collected in this study.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D054969 | Primary Dysautonomias |
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Measurement of arterial stiffness using pulse wave velocity.
| Baseline (Day 1 study visit) |
| Heart Rate Recovery | Rate of decrease in heart rate following completion of graded exercise testing on a cycle ergometer. | Immediately after graded exercise testing at the study visit (Day 1) |
Change in heart rate during standardized orthostatic testing.
| During orthostatic testing at the study visit (Day 1) |
| 30190008 | Background | Freeman R, Abuzinadah AR, Gibbons C, Jones P, Miglis MG, Sinn DI. Orthostatic Hypotension: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018 Sep 11;72(11):1294-1309. doi: 10.1016/j.jacc.2018.05.079. |
| 37345492 | Background | Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26. |
| D054971 | Orthostatic Intolerance |
| D007022 | Hypotension |