How blood pressure and heart rate respond to standing and exercise in healthy people and those with high blood pressure
Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise
See if blood pressure, heart rate, and arterial stiffness during standing and graded bike exercise differ between healthy young adults and older adults with controlled high blood pressure, including those with orthostatic problems or diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07482462 on ClinicalTrials.gov |
What this trial studies
This is an observational physiology study comparing healthy young adults and older adults with controlled arterial hypertension, with further subgrouping by orthostatic blood pressure responses and diabetes. Participants undergo orthostatic testing, graded exercise on a cycle ergometer, electrocardiography, and measurements of arterial stiffness such as pulse wave velocity alongside other hemodynamic parameters. Heart rate variability and heart rate recovery after exercise are recorded, and available clinical data including ambulatory blood pressure monitoring and labs from routine care are incorporated. The goal is to characterize autonomic regulation and vascular responses across groups rather than to test an intervention.
Who should consider this trial
Good fit: Ideal candidates are healthy non-smoking adults aged 18–35 with BMI 20–24.9 and older adults (≥60) with controlled arterial hypertension, including those with orthostatic hypotension, orthostatic hypertension, or coexisting diabetes, who can give informed consent.
Not a fit: People with uncontrolled or unstable hypertension, diagnosed autonomic neuropathy, dementia or other neurodegenerative conditions, active smokers, or those unable to attend on-site testing are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the findings could help clinicians recognize autonomic dysfunction earlier and refine how blood pressure responses to standing and exercise are managed in patients with hypertension.
How similar studies have performed: Previous observational studies have linked arterial stiffness, heart rate variability, and abnormal blood pressure responses, so this work builds on existing evidence rather than testing a novel therapy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ljubljana
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: Amela Kabaklić, MD, PhD — University Medical Centre Ljubljana
- Study coordinator: Amela Kabaklić, MD, PhD
- Email: amela.kabaklic@kclj.si
- Phone: +386 1 522 43 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.