HypertensionNCT07482462
Autonomic Regulation of Blood Pressure and Heart Rate During Orthostasis and Exercise in Healthy and Hypertensive Individuals
An observational study of Hypertension and Autonomic Dysfunction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Autonomic Dysfunction, Orthostatic Hypotension
- How many people
- 120 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Oct 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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 join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Amela Kabaklić, MD, PhD, +386 1 522 43 05, amela.kabaklic@kclj.si
Timur Mušić, MD
About this study
Official title: Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise
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.
Read the detailed description
The autonomic nervous system plays an important role in the regulation of cardiovascular responses to orthostatic stress and physical exercise. Alterations in autonomic regulation may contribute to abnormal blood pressure responses, orthostatic hypotension, or exaggerated blood pressure responses during exercise, particularly in individuals with arterial hypertension.
The aim of this study is to assess arterial stiffness and autonomic regulation of blood pressure and heart rate in healthy individuals and people with arterial hypertension. The study includes healthy young adults and older adults with hypertension who are followed at the Department of Hypertension. Older participants are further categorized into subgroups including hypertension, hypertension with orthostatic hypotension, hypertension with orthostatic hypertension, and hypertension with diabetes mellitus.
All participants undergo standardized cardiovascular evaluation including orthostatic testing, graded exercise testing on a cycle ergometer, electrocardiography, and measurement of arterial stiffness parameters such as pulse wave velocity. During these procedures, blood pressure responses, heart rate variability, and heart rate recovery after exercise are assessed. Additional vascular and hemodynamic parameters are also recorded.
Additional clinical data, including laboratory test results and ambulatory blood pressure monitoring (ABPM) obtained as part of routine outpatient care prior to study participation, are collected from medical records for participants with hypertension with their written informed consent.
The study aims to improve understanding of cardiovascular autonomic regulation and vascular function in both healthy individuals and people with hypertension and related conditions.
- Conditions
- Hypertension, Autonomic Dysfunction, Orthostatic Hypotension
- Keywords
- Orthostatic Test, Arterial Stiffness, Exercise Testing, Heart Rate Variability, Pulse Wave Velocity
- Medical subject headings
- Hypertension, Primary Dysautonomias, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Assessment of heart rate variability parameters during orthostatic testing and graded exercise testing as indicators of autonomic cardiovascular regulation.
Measured: Baseline (Day 1 study visit)
Secondary outcomes (3)
Blood Pressure Response to Exercise
Assessment of systolic and diastolic blood pressure response during graded exercise testing on a cycle ergometer.
Measured: During graded exercise testing at the study visit (Day 1)
Pulse Wave Velocity
Measurement of arterial stiffness using pulse wave velocity.
Measured: Baseline (Day 1 study visit)
Heart Rate Recovery
Rate of decrease in heart rate following completion of graded exercise testing on a cycle ergometer.
Measured: Immediately after graded exercise testing at the study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amela Kabaklić, University Medical Centre Ljubljana
- Investigators
- Amela Kabaklić, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482462
- Sponsor's protocol ID
- OHHR-2025
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations related to clinical data collected in this study.
Publications
Pecanha T, Silva-Junior ND, Forjaz CL. Heart rate recovery: autonomic determinants, methods of assessment and association with mortality and cardiovascular diseases. Clin Physiol Funct Imaging. 2014 Sep;34(5):327-39. doi: 10.1111/cpf.12102. Epub 2013 Nov 17.
PubMed 24237859Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
PubMed 29034226Freeman R, Abuzinadah AR, Gibbons C, Jones P, Miglis MG, Sinn DI. Orthostatic Hypotension: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018 Sep 11;72(11):1294-1309. doi: 10.1016/j.jacc.2018.05.079.
PubMed 30190008Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 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). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26.
PubMed 37345492
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise
- ClinicalTrials.gov ID
- NCT07482462
- Acronym / sponsor ID
- OHHR-2025
- Conditions
- Hypertension, Autonomic Dysfunction, Orthostatic Hypotension
- Keywords
- Orthostatic Test, Arterial Stiffness, Exercise Testing, Heart Rate Variability, Pulse Wave Velocity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The autonomic nervous system plays an important role in the regulation of cardiovascular responses to orthostatic stress and physical exercise. Alterations in autonomic regulation may contribute to abnormal blood pressure responses, orthostatic hypotension, or exaggerated blood pressure responses during exercise, particularly in individuals with arterial hypertension.
The aim of this study is to assess arterial stiffness and autonomic regulation of blood pressure and heart rate in healthy individuals and people with arterial hypertension. The study includes healthy young adults and older adults with hypertension who are followed at the Department of Hypertension. Older participants are further categorized into subgroups including hypertension, hypertension with orthostatic hypotension, hypertension with orthostatic hypertension, and hypertension with diabetes mellitus.
All participants undergo standardized cardiovascular evaluation including orthostatic testing, graded exercise testing on a cycle ergometer, electrocardiography, and measurement of arterial stiffness parameters such as pulse wave velocity. During these procedures, blood pressure responses, heart rate variability, and heart rate recovery after exercise are assessed. Additional vascular and hemodynamic parameters are also recorded.
Additional clinical data, including laboratory test results and ambulatory blood pressure monitoring (ABPM) obtained as part of routine outpatient care prior to study participation, are collected from medical records for participants with hypertension with their written informed consent.
The study aims to improve understanding of cardiovascular autonomic regulation and vascular function in both healthy individuals and people with hypertension and related conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Rate Variability
Time frame: Baseline (Day 1 study visit)
Assessment of heart rate variability parameters during orthostatic testing and graded exercise testing as indicators of autonomic cardiovascular regulation.
3 secondary outcomes
Blood Pressure Response to Exercise
Time frame: During graded exercise testing at the study visit (Day 1)
Pulse Wave Velocity
Time frame: Baseline (Day 1 study visit)
Heart Rate Recovery
Time frame: Immediately after graded exercise testing at the study visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 24237859Pecanha T, Silva-Junior ND, Forjaz CL. Heart rate recovery: autonomic determinants, methods of assessment and association with mortality and cardiovascular diseases. Clin Physiol Funct Imaging. 2014 Sep;34(5):327-39. doi: 10.1111/cpf.12102. Epub 2013 Nov 17.
- Background: PubMed 29034226Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
- Background: PubMed 30190008Freeman R, Abuzinadah AR, Gibbons C, Jones P, Miglis MG, Sinn DI. Orthostatic Hypotension: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018 Sep 11;72(11):1294-1309. doi: 10.1016/j.jacc.2018.05.079.
- Background: PubMed 37345492Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 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). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations related to clinical data collected in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amela Kabaklić, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Autonomic Dysfunction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amela Kabaklić, MD, PhD (+386 1 522 43 05, amela.kabaklic@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Baseline (Day 1 study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07482462, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.