How blood pressure and heart rate respond to standing and exercise in healthy people and those with high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.