An observational study in Resistant Hypertension, Medication Adherence and Autonomic Nervous System, sponsored by Nemocnice AGEL Trinec-Podlesi a.s.. Enrolling by invitation at 1 site in Czechia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Nemocnice AGEL Trinec-Podlesi a.s. · Observational
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.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's planned enrollment of 150 is below the median of 250 across 148 observational studies indexed under Medication Adherence.
Browse Medication Adherence studies →Nemocnice AGEL Trinec-Podlesi a.s. is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single cohort analysed by adherence status defined by TDM: adherent vs non-adherent.
Diagnostic Test: Heart rate variability recording (Polar H10) · · Diagnostic Test: Therapeutic drug monitoring (antihypertensive drug levels) · Other: Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ)
Short-term (10-15 min) seated HRV; time-domain (SDNN, RMSSD, pNN50) and frequency-domain (LF, HF, LF/HF) parameters.
Single blood draw measuring antihypertensive drug levels; defines adherent vs non-adherent status.
Self-completed instruments assessing medication adherence, mood, quality of life, and physical activity.
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.
Time frame: At the single study visit (Day 1)
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.
Time frame: At the single study visit (Day 1)
Questionnaire scores in relation to adherence and HRV
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.
Time frame: 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).
Time frame: At the single study visit (Day 1)
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nemocnice AGEL Trinec-Podlesi a.s.