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Recruiting NCT07482462

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

— Observational Hypertension Autonomic Dysfunction Orthostatic Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hypertension, Autonomic Dysfunction, Orthostatic Hypotension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • Heart Rate Variability [Time frame: Baseline (Day 1 study visit)]
Secondary outcome measures (3)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Refusal or inability to provide written informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Slovenia · 1 center
  • University Medical Centre Ljubljana — Ljubljana

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. PMID 24237859
  • 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
  • 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
  • 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 PMID 37345492

Identifiers

NCT: NCT07482462 · OHHR-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗