Heart Rate Variability and Medication Adherence in Resistant Hypertension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNemocnice AGEL Trinec-Podlesi a.s.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Heart rate variability recording (Polar H10) ·
- Therapeutic drug monitoring (antihypertensive drug levels)
- Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ)
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Nemocnice AGEL Trinec-Podlesi a.s.
Lead sponsor
Masaryk University
Collaborator
Source ClinicalTrials.gov