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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Heart rate variability recording (Polar H10) ·
Diagnostic testShort-term (10-15 min) seated HRV; time-domain (SDNN, RMSSD, pNN50) and frequency-domain (LF, HF, LF/HF) parameters.
Therapeutic drug monitoring (antihypertensive drug levels)
Diagnostic testSingle blood draw measuring antihypertensive drug levels; defines adherent vs non-adherent status.
Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ)
Other interventionSelf-completed instruments assessing medication adherence, mood, quality of life, and physical activity.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm)3 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
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)2
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)3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nemocnice AGEL Trinec-Podlesi a.s.
Lead sponsor
Masaryk University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: