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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population includes healthy young adults and older adults with arterial hypertension who are followed at the Department of Hypertension, University Medical Centre Ljubljana. Participants with hypertension are categorized into subgroups including hypertension without orthostatic blood pressure abnormalities, hypertension with orthostatic hypotension, hypertension with orthostatic hypertension, and hypertension with diabetes.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 5 trial groups
Group A: Healthy Young Adults
Group B: Hypertension
Group C: Hypertension With Orthostatic Hypotension
Group D: Hypertension With Diabetes
Group E: Hypertension With Orthostatic Hypertension

Trial outcomes

Primary outcomes

1

Heart Rate Variability

Assessment of heart rate variability parameters during orthostatic testing and graded exercise testing as indicators of autonomic cardiovascular regulation.

Time frame
Baseline (Day 1 study visit)

Secondary outcomes

1

Blood Pressure Response to Exercise

Assessment of systolic and diastolic blood pressure response during graded exercise testing on a cycle ergometer.

Time frame
During graded exercise testing at the study visit (Day 1)
2

Pulse Wave Velocity

Measurement of arterial stiffness using pulse wave velocity.

Time frame
Baseline (Day 1 study visit)
3

Heart Rate Recovery

Rate of decrease in heart rate following completion of graded exercise testing on a cycle ergometer.

Time frame
Immediately after graded exercise testing at the study visit (Day 1)

Other outcomes

1

Orthostatic Blood Pressure Response

Assessment of changes in systolic and diastolic blood pressure during standardized orthostatic testing.

Time frame
During orthostatic testing at the study visit (Day 1)
2

Orthostatic Heart Rate Response

Change in heart rate during standardized orthostatic testing.

Time frame
During orthostatic testing at the study visit (Day 1)

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