How Blood Pressure and Heart Rate Respond to Standing and Exercise in Hypertension
Observes heart and blood vessel responses to standing and cycling in adults with hypertension.
Key facts
- Who runs it
- University Medical Centre Ljubljana
- Where
- Ljubljana, SloveniaSee the site
- Trial code
- Registry title
- Autonomic Regulation of Blood Pressure and Heart Rate During Orthostasis and Exercise in Healthy and Hypertensive Individuals
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 15 Oct 2025
- Expected to end
- Mar 2027
- Type of study
- Observational, 5 groups
- Record updated
- 19 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults aged 18-35 and for people aged 60 or older with controlled high blood pressure. They take a standing test and an exercise test on a bike.
- Age
- Healthy volunteers: 18-35 years. People with high blood pressure: 60 years or older.
- Sex
- All sexes can join.
- Disease stage
- Controlled arterial hypertension (high blood pressure). Groups: negative standing (orthostatic) test; orthostatic hypotension; rise in blood pressure on standing; hypertension with diabetes and no known autonomic dysfunction.
- Earlier treatment
- No change in blood pressure medicine in the last 4 weeks. No antiarrhythmic drugs (class I, III, or IV), digoxin, alpha-receptor blockers, or other drugs that strongly affect heart rate variability or autonomic function.
- Biomarker or test result
- Healthy volunteers: BMI 20-24.9 kg/m² and negative orthostatic test. Hypertension groups: result of the orthostatic test (negative, orthostatic hypotension, or blood pressure rise).
Main reasons for not taking part
- Known heart or vascular disease, such as heart failure (NYHA II-IV), heart attack in the last 6 months, serious arrhythmia, or peripheral arterial occlusive disease
- Uncontrolled high blood pressure
- Pacemaker
- Advanced kidney failure (eGFR <30 mL/min/1.73 m²), advanced liver failure, or active cancer
- BMI of 35 or more, current smoking, pregnancy or breastfeeding
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Advanced renal failure (eGFR <30 mL/min/1.73 m²) or advanced liver failure
- 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
Where in Slovenia
- University Medical Centre LjubljanaLjubljana, SloveniaContact: Amela Kabaklić, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 5 groups in the trial
- Healthy Young Adults
Healthy volunteers aged 18-35 years without known cardiovascular disease.
- Hypertension
Participants with arterial hypertension without orthostatic blood pressure abnormalities during orthostatic testing and without diabetes.
- Hypertension With Orthostatic Hypotension
Participants with arterial hypertension and orthostatic hypotension identified during orthostatic testing.
- Hypertension With Diabetes
Participants with arterial hypertension and coexisting diabetes.
- Hypertension With Orthostatic Hypertension
Participants with arterial hypertension and orthostatic hypertension identified during orthostatic testing.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise
- Plain-language title
- How Blood Pressure and Heart Rate Respond to Standing and Exercise in HypertensionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 March 2026