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| ID | Type | Description | Link |
|---|---|---|---|
| EK 29/25 | Other Identifier | Ethics Committee, AGEL Třinec-Podlesí Hospital |
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| Name | Class |
|---|---|
| Masaryk University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm) | Single cohort analysed by adherence status defined by TDM: adherent vs non-adherent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart rate variability recording (Polar H10) · | Diagnostic Test | Short-term (10-15 min) seated HRV; time-domain (SDNN, RMSSD, pNN50) and frequency-domain (LF, HF, LF/HF) parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability parameters by TDM-defined adherence | 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. | At the single study visit (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability in relation to office blood-pressure control | Association between HRV parameters and office blood pressure measured seated immediately before the HRV recording. | At the single study visit (Day 1) |
| Questionnaire scores in relation to adherence and HRV |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (18-75 years) with essential hypertension treated with at least three antihypertensive drugs of different classes, including at least one diuretic (resistant hypertension), and in sinus rhythm. Participants are identified and recruited opportunistically, in a nurse-led manner, among patients attending a one-day-care cardiology unit at a single center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Alexander Mohr, MD | Contact | +420724173927 | jan.mohr@npo.agel.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jan Alexander Mohr, MD | Nemocnice AGEL Třinec-Podlesí a.s. | Principal Investigator |
| Matej Pekar, MD, PhD | Nemocnice AGEL Třinec-Podlesí a.s. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice AGEL Třinec-Podlesí a.s. | Třinec | Moravian-Silesian Region | 739 61 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24917035 | Background | Ladova K, Matoulkova P, Zadak Z, Macek K, Vyroubal P, Vlcek J, Morisky DE. Self-reported adherence by MARS-CZ reflects LDL cholesterol goal achievement among statin users: validation study in the Czech Republic. J Eval Clin Pract. 2014 Oct;20(5):671-7. doi: 10.1111/jep.12201. Epub 2014 Jun 11. | |
| 8598068 | Background |
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| Therapeutic drug monitoring (antihypertensive drug levels) | Diagnostic Test | Single blood draw measuring antihypertensive drug levels; defines adherent vs non-adherent status. |
|
| Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ) | Other | Self-completed instruments assessing medication adherence, mood, quality of life, and physical activity. |
|
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. |
| At the single study visit (Day 1) |
| Prevalence of non-adherence by therapeutic drug monitoring | Proportion of patients classified as non-adherent to antihypertensive therapy based on TDM (absent or subtherapeutic drug levels). | At the single study visit (Day 1) |
| Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available. |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016903 | Drug Monitoring |
| D011795 | Surveys and Questionnaires |
| D000073222 | Patient Health Questionnaire |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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