NCT07482462 Autonomic Regulation of Blood Pressure and Heart Rate During Orthostasis and Exercise in Healthy and Hypertensive Individuals
| NCT ID | NCT07482462 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-10-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Healthy volunteers aged 18-35 years without known acute or chronic disease, non-smokers, body mass index (BMI) 20-24.9 kg/m², and negative orthostatic test * Participants aged ≥60 years with arterial hypertension followed at the Department of Hypertension * Hypertension group: controlled arterial hypertension, negative orthostatic test, without diabetes mellitus * Hypertension with orthostatic hypotension group: controlled arterial hypertension and positive orthostatic test indicating orthostatic hypotension * Hypertension with orthostatic hypertension group: controlled arterial hypertension and positive orthostatic test indicating a rise in blood pressure during orthostatic testing * Hypertension with diabetes mellitus group: controlled arterial hypertension and diabetes mellitus without previously diagnosed autonomic dysfunction * Ability to provide written informed consent Exclusion Criteria: * Dementia, neurodegenerative disease, or cognitive impairment preventing understanding of study procedures * Known cardiovascular disease including heart failure (NYHA II-IV), myocardial infarction within the previous 6 months, clinically significant arrhythmias, or peripheral arterial occlusive disease * Uncontrolled arterial hypertension * Change in antihypertensive therapy within the previous 4 weeks * Presence of a cardiac pacemaker * Treatment with antiarrhythmic drugs (class I, III, or IV), digoxin, alpha-receptor blockers, or other medications known to significantly affect heart rate variability or autonomic function * Advanced renal failure (eGFR \<30 mL/min/1.73 m²) or advanced liver failure * Active malignancy * Body mass index ≥35 kg/m² * Acute illness within the previous 4 weeks * Current smoking * Inability to safely perform exercise testing on a cycle ergometer * Severe psychiatric disorders without stable treatment * Pregnancy or breastfeeding * Participation in another clinical study * Refusal or inability to provide written informed consent
Contact & Investigator
Amela Kabaklić, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Centre Ljubljana
Frequently Asked Questions
Who can join the NCT07482462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07482462 currently recruiting?
Yes, NCT07482462 is actively recruiting participants. Contact the research team at amela.kabaklic@kclj.si for enrollment information.
Where is the NCT07482462 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07482462 clinical trial?
NCT07482462 is sponsored by University Medical Centre Ljubljana. The principal investigator is Amela Kabaklić, MD, PhD at University Medical Centre Ljubljana. The trial plans to enroll 120 participants.