Resistant HypertensionHRV-HYP-1NCT07707583
Heart Rate Variability and Medication Adherence in Resistant Hypertension
An observational study of Resistant Hypertension and Medication Adherence, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resistant Hypertension, Medication Adherence, Autonomic Nervous System
- What is being tested?
- Heart rate variability recording (Polar H10) ·, Therapeutic drug monitoring (antihypertensive drug levels) and Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ)
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 26 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Nemocnice AGEL Třinec-Podlesí a.s.
Třinec, Moravian-Silesian Region, 739 61
About this study
Official title: Eart Rate Variability, Medication Adherence, and Blood Pressure Control in Resistant Hypertension: A Cross-Sectional Study
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.
Read the detailed description
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.
- Being tested
- Heart rate variability recording (Polar H10) ·, Therapeutic drug monitoring (antihypertensive drug levels), Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ)
- Keywords
- Heart Rate Variability, Medication Adherence, Therapeutic Drug Monitoring, Resistant Hypertension, Autonomic Function, Compliance, HRV, Antihypertensive Agents, Blood Pressure
- Medical subject headings
- Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm) | Single cohort analysed by adherence status defined by TDM: adherent vs non-adherent. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the single study visit (Day 1)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: At the single study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start26 Oct 2026
- Primary completion26 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Matej Pekar, MD, PhD, Nemocnice AGEL Trinec-Podlesi a.s.
- Investigators
- Jan Alexander Mohr, MD, Principal investigator, Nemocnice AGEL Třinec-Podlesí a.s.Matej Pekar, MD, PhD, Study director, Nemocnice AGEL Třinec-Podlesí a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707583
- Sponsor's protocol ID
- HRV-HYP-1
- Other IDs
- EK 29/25
- Acronym
- HRV-HYP-1
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24917035Heart 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.
PubMed 8598068
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eart Rate Variability, Medication Adherence, and Blood Pressure Control in Resistant Hypertension: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07707583
- Acronym / sponsor ID
- HRV-HYP-1 / HRV-HYP-1
- Keywords
- Heart Rate Variability, Medication Adherence, Therapeutic Drug Monitoring, Resistant Hypertension, Autonomic Function, Compliance, HRV, Antihypertensive Agents
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.University, hospital or other
- Collaborators
- Masaryk University
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 26 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm) | – | 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)Single cohort analysed by adherence status defined by TDM: adherent vs non-adherent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability recording (Polar H10) ·Short-term (10-15 min) seated HRV; time-domain (SDNN, RMSSD, pNN50) and frequency-domain (LF, HF, LF/HF) parameters. | Diagnostic test | Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm) |
| Therapeutic drug monitoring (antihypertensive drug levels)Single blood draw measuring antihypertensive drug levels; defines adherent vs non-adherent status. | Diagnostic test | Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm) |
| Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ)Self-completed instruments assessing medication adherence, mood, quality of life, and physical activity. | Other | Resistant hypertension (≥3 antihypertensives incl. diuretic, sinus rhythm) |
Primary outcome
Heart rate variability parameters by TDM-defined adherence
Time frame: At the single study visit (Day 1)
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.
3 secondary outcomes
Heart rate variability in relation to office blood-pressure control
Time frame: At the single study visit (Day 1)
Questionnaire scores in relation to adherence and HRV
Time frame: At the single study visit (Day 1)
Prevalence of non-adherence by therapeutic drug monitoring
Time frame: At the single study visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 24917035Ladova 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.
- Background: PubMed 8598068Heart 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Alexander Mohr, MD principal investigator
Nemocnice AGEL Třinec-Podlesí a.s.
Matej Pekar, MD, PhD study director
Nemocnice AGEL Třinec-Podlesí a.s.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resistant Hypertension and Medication Adherence, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability parameters by TDM-defined adherence (time frame: At the single study visit (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07707583, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.