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Набор скоро начнётся NCT07707583

Heart Rate Variability and Medication Adherence in Resistant Hypertension

— Наблюдательное Resistant Hypertension Medication Adherence Autonomic Nervous System

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Heart rate variability recording (Polar H10) ·, Therapeutic drug monitoring (antihypertensive drug levels), Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ).
Кому может быть актуально
Состояния в реестре: Resistant Hypertension, Medication Adherence, Autonomic Nervous System. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чехия
Следующий шаг
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Официальное название

Eart Rate Variability, Medication Adherence, and Blood Pressure Control in Resistant Hypertension: A Cross-Sectional Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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.
  • Диагностический тест Therapeutic drug monitoring (antihypertensive drug levels)
    Single blood draw measuring antihypertensive drug levels; defines adherent vs non-adherent status.
  • Другое Questionnaires (MARS-CZ, PHQ-9, SF-36, IPAQ)
    Self-completed instruments assessing medication adherence, mood, quality of life, and physical activity.

Первичные конечные точки

  • Heart rate variability parameters by TDM-defined adherence [Срок оценки: At the single study visit (Day 1)]
Вторичные конечные точки (3)
  • Heart rate variability in relation to office blood-pressure control [Срок оценки: At the single study visit (Day 1)]
  • Questionnaire scores in relation to adherence and HRV [Срок оценки: At the single study visit (Day 1)]
  • Prevalence of non-adherence by therapeutic drug monitoring [Срок оценки: At the single study visit (Day 1)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Чехия · 1 центр
  • Nemocnice AGEL Třinec-Podlesí a.s. — Třinec

Публикации

  • 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
  • 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

Идентификаторы

NCT: NCT07707583 · HRV-HYP-1 · EK 29/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗