Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07482462

Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise

Led by University Medical Centre Ljubljana · Updated on 2026-03-19

120

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the autonomic nervous system controls blood pressure and heart rate during standing and exercise in both healthy adults and people with arterial hypertension. The study focuses on understanding cardiovascular responses to exercise on a cycle ergometer and includes groups with hypertension and related conditions like orthostatic hypotension and diabetes. This observational study aims to improve knowledge of cardiovascular regulation and may help identify autonomic dysfunction earlier for better clinical care. Participants include healthy young adults aged 18 to 35 without cardiovascular disease and several subgroups of older adults with controlled arterial hypertension, with or without orthostatic blood pressure abnormalities or diabetes. All participants undergo tests such as orthostatic testing, graded exercise on a cycle ergometer, electrocardiography, and arterial stiffness measurements like pulse wave velocity. Additional vascular and hemodynamic parameters are also recorded during these procedures. During the single study visit, researchers assess heart rate variability, blood pressure response to exercise, and heart rate recovery immediately after exercise. Clinical data including lab results and ambulatory blood pressure monitoring are collected from medical records for participants with hypertension. The study monitors cardiovascular function and autonomic regulation to contribute to better understanding and management of hypertension and related conditions.

CONDITIONS

Brief Title

Autonomic Regulation of Blood Pressure and Heart Rate During Orthostasis and Exercise in Healthy and Hypertensive Individuals

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy volunteers aged 18 to 35 years without known acute or chronic disease
  • Non-smokers with body mass index between 20 and 24.9 kg/m8
  • Participants aged 60 years or older with arterial hypertension followed at the Department of Hypertension
  • Controlled arterial hypertension without diabetes and negative orthostatic test
  • Controlled arterial hypertension with orthostatic hypotension indicated by positive orthostatic test
  • Controlled arterial hypertension with orthostatic hypertension indicated by positive orthostatic test
  • Controlled arterial hypertension with diabetes mellitus without diagnosed autonomic dysfunction
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Dementia, neurodegenerative disease, or cognitive impairment preventing understanding of study procedures
  • Known cardiovascular disease including heart failure (NYHA II-IV), recent myocardial infarction, 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 medications affecting heart rate variability or autonomic function such as antiarrhythmics, digoxin, or alpha-receptor blockers
  • Advanced kidney or liver failure
  • Active cancer
  • Body mass index of 35 kg/m8 or higher
  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo standardized cardiovascular evaluations including orthostatic testing, graded exercise testing on a cycle ergometer, electrocardiography, and measurement of arterial stiffness parameters.

1 study visit (in-person)

Long-term Monitoring

Duration - Variable prior to study visit

Participants with hypertension have additional clinical data collected from medical records including laboratory tests and ambulatory blood pressure monitoring obtained as part of routine outpatient care prior to study participation.

Data collected from medical records (no additional visits)

Trial Site Locations

Total: 1 location

1

University Medical Centre Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

A

Amela Kabaklić, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Published Research Related To This Trial

Heart rate recovery: autonomic determinants, methods of assessment and association with mortality and cardiovascular diseases.

Tiago Peçanha, Natan Daniel Silva-Júnior, Cláudia Lúcia de Moraes Forjaz

https://pubmed.ncbi.nlm.nih.gov/24237859

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).

Giuseppe Mancia, Reinhold Kreutz, Mattias Brunström...

https://pubmed.ncbi.nlm.nih.gov/37345492