NCT07482462Recruiting
Autonomic Regulation of Blood Pressure and Heart Rate During Orthostasis and Exercise in Healthy and Hypertensive Individuals
Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 11 Mar 2026
- Start date
- 15 Oct 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- High blood pressure
- NCT number
- NCT07482462
What you commit to
- Study type: Observational
- Planned participants: 120
- From 15 Oct 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known cardiovascular disease including heart failure (NYHA II-IV), myocardial infarction within the previous 6 months, clinically significant arrhythmias, or peripheral arterial occlusive disease
- Change in antihypertensive therapy within the previous 4 weeks
- 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
- Acute illness within the previous 4 weeks
Other illness
- Dementia, neurodegenerative disease, or cognitive impairment preventing understanding of study procedures
- Uncontrolled arterial hypertension
- Presence of a cardiac pacemaker
- Active malignancy
- Severe psychiatric disorders without stable treatment
Lab values
- Advanced renal failure (eGFR \<30 mL/min/1.73 m²) or advanced liver failure
Other
- Body mass index ≥35 kg/m²
- Current smoking
- Inability to safely perform exercise testing on a cycle ergometer
- Pregnancy or breastfeeding
- Participation in another clinical study
- Refusal or inability to provide written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.