Eart Rate Variability, Medication Adherence, and Blood Pressure Control in Resistant Hypertension: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Heart rate variability parameters by TDM-defined adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Heart rate variability parameters by TDM-defined adherence
时间窗: 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.
次要结局
- 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))
研究者
Matej Pekar, MD, PhD
Principal Investigator
Nemocnice AGEL Trinec-Podlesi a.s.