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

NCT07482462 | Recruiting

• 1 other identifier: OHHR-2025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension; Autonomic Dysfunction; Orthostatic Hypotension

Keywords

Orthostatic Test; Arterial Stiffness; Exercise Testing; Heart Rate Variability; Pulse Wave Velocity

Outcome Measures

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.

  Baseline (Day 1 study visit)

Secondary Outcomes (3)

• Blood Pressure Response to Exercise

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

• Pulse Wave Velocity

  Baseline (Day 1 study visit)

• Heart Rate Recovery

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

Other Outcomes (2)

• Orthostatic Blood Pressure Response

  During orthostatic testing at the study visit (Day 1)

• Orthostatic Heart Rate Response

  During orthostatic testing at the study visit (Day 1)

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (4)

• 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.

  PMID: 24237859 BACKGROUND

• Shaffer 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.

  PMID: 29034226 BACKGROUND

• Freeman 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.

  PMID: 30190008 BACKGROUND

• Mancia 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.

  PMID: 37345492 BACKGROUND

MeSH Terms

Conditions

Hypertension; Primary Dysautonomias; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Autonomic Nervous System Diseases; Nervous System Diseases; Orthostatic Intolerance; Hypotension

Study Officials

• Amela Kabaklić, MD, PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amela Kabaklić, MD, PhD

CONTACT

+386 1 522 43 05; amela.kabaklic@kclj.si

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Specialist in Internal Medicine, Division of Internal Medicine, Department of Hypertension

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 19, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)