Autonomic Nervous System, Medication Adherence, Resistant Hypertension
Conditions
Keywords
Heart Rate Variability, Medication Adherence, Therapeutic Drug Monitoring, Resistant Hypertension, Autonomic Function, Compliance, HRV, Antihypertensive Agents, Blood Pressure
Brief summary
This single-center, cross-sectional observational study examines the relationship between adherence to antihypertensive therapy - verified objectively by therapeutic drug monitoring (TDM) - and heart rate variability (HRV) in patients with resistant hypertension. Patients are recruited opportunistically, in a nurse-led manner, in a one-day-care cardiology unit, and undergo a single examination: a short-term HRV recording (Polar H10), a single blood draw for antihypertensive drug levels, office blood pressure, and self-completed questionnaires. There is no follow-up.
Detailed description
Non-adherence to antihypertensive medication is a major cause of apparently resistant hypertension and confounds interpretation of autonomic measures. HRV is a non-invasive index of autonomic cardiac regulation and is systematically influenced by antihypertensive drugs. The study tests whether TDM-verified intake of antihypertensives is reflected in HRV parameters, and whether HRV can serve as a complementary marker of adherence. Adherence is determined by TDM (the objective gold standard); a self-report questionnaire (MARS-CZ) is collected as a secondary, descriptive measure. HRV is recorded for 10-15 minutes seated, before sedation and before heparin/contrast; the blood sample is drawn before heparin/contrast, with the time of last dose recorded. Time-domain (SDNN, RMSSD, pNN50) and frequency-domain (LF, HF, LF/HF) HRV parameters are analysed. Approximately 100-200 patients are planned for enrolment. It does not interfere with the patient's planned cardiac procedure; the one-day-care unit is the recruitment venue only.
Interventions
DIAGNOSTIC_TESTHeart rate variability recording (Polar H10) ·
Short-term (10-15 min) seated HRV; time-domain (SDNN, RMSSD, pNN50) and frequency-domain (LF, HF, LF/HF) parameters.
DIAGNOSTIC_TESTTherapeutic drug monitoring (antihypertensive drug levels)
Single blood draw measuring antihypertensive drug levels; defines adherent vs non-adherent status.
OTHERQuestionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ)
Self-completed instruments assessing medication adherence, mood, quality of life, and physical activity.
Sponsors
Nemocnice AGEL Trinec-Podlesi a.s.
Masaryk University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years with diagnosed essential hypertension * Treated with ≥3 antihypertensive drugs of different classes, including ≥1 diuretic (resistant hypertension) * Sinus rhythm * Able to give informed consent and understand Czech
Exclusion criteria
* Absence of sinus rhythm: atrial fibrillation/flutter, ventricular arrhythmias, higher-degree AV block, pacemaker/ICD with sustained pacing, sustained SVT, or significant ectopy * Secondary hypertension * Pregnancy or breastfeeding * Cognitive impairment precluding informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability parameters by TDM-defined adherence | At the single study visit (Day 1) | Time-domain (SDNN, RMSSD, pNN50) and frequency-domain (LF, HF, LF/HF ratio) HRV parameters from a short-term seated recording, compared between TDM-adherent and TDM-non-adherent patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability in relation to office blood-pressure control | At the single study visit (Day 1) | Association between HRV parameters and office blood pressure measured seated immediately before the HRV recording. |
| Questionnaire scores in relation to adherence and HRV | At the single study visit (Day 1) | Scores of MARS-CZ (adherence), PHQ-9 (mood), SF-36 (quality of life), and IPAQ (physical activity) examined against TDM-defined adherence and HRV parameters. |
| Prevalence of non-adherence by therapeutic drug monitoring | At the single study visit (Day 1) | Proportion of patients classified as non-adherent to antihypertensive therapy based on TDM (absent or subtherapeutic drug levels). |
Countries
Czechia
Contacts
CONTACTJan Alexander Mohr, MD
PRINCIPAL_INVESTIGATORJan Alexander Mohr, MD
Nemocnice AGEL Třinec-Podlesí a.s.
STUDY_DIRECTORMatej Pekar, MD, PhD
Nemocnice AGEL Třinec-Podlesí a.s.
Outcome results
None listed