Heart Rate Variability and Medication Adherence in Resistant Hypertension

NCT07707583 | Not Yet Recruiting

• 2 other identifiers: HRV-HYP-1EK 29/25
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Resistant Hypertension; Medication Adherence; Autonomic Nervous System

Keywords

Heart Rate Variability; Medication Adherence; Therapeutic Drug Monitoring; Resistant Hypertension; Autonomic Function; Compliance; HRV; Antihypertensive Agents; Blood Pressure

Outcome Measures

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.

  At the single study visit (Day 1)

Secondary Outcomes (3)

• Heart rate variability in relation to office blood-pressure control

  At the single study visit (Day 1)

• Questionnaire scores in relation to adherence and HRV

  At the single study visit (Day 1)

• Prevalence of non-adherence by therapeutic drug monitoring

  At the single study visit (Day 1)

Study Arms (1)

Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm)

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)

Interventions

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.

Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm)

Therapeutic drug monitoring (antihypertensive drug levels) DIAGNOSTIC_TEST

Single blood draw measuring antihypertensive drug levels; defines adherent vs non-adherent status.

Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm)

Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ) OTHER

Self-completed instruments assessing medication adherence, mood, quality of life, and physical activity.

Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemocnice AGEL Trinec-Podlesi a.s.: lead
• Masaryk University: collaborator

Study Sites (1)

Nemocnice AGEL Třinec-Podlesí a.s.

Třinec, Moravian-Silesian Region, 739 61, Czechia

Location

Related Publications (2)

• 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.

  PMID: 24917035 BACKGROUND

• 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.

  PMID: 8598068 BACKGROUND

MeSH Terms

Conditions

Medication Adherence; Patient Compliance

Interventions

Drug Monitoring; Surveys and Questionnaires; Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Jan Alexander Mohr, MD

  Nemocnice AGEL Třinec-Podlesí a.s.

  PRINCIPAL INVESTIGATOR

• Matej Pekar, MD, PhD

  Nemocnice AGEL Třinec-Podlesí a.s.

  STUDY DIRECTOR

Central Study Contacts

Jan Alexander Mohr, MD

CONTACT

+420724173927; jan.mohr@npo.agel.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

CZ (1)