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Идёт набор NCT06823570

Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension.

Без фазы С лечением Hypertension Vascular Function Fitness Testing Metabolism Changes

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: Individualized exercise therapy, Lifestyle recommendations.
Кому может быть актуально
Состояния в реестре: Hypertension, Vascular Function, Fitness Testing, Metabolism Changes. Базовые параметры: от 18 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension. A Randomized Controlled Trial.

Обзор

This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.

Подробное описание

Arterial hypertension is a global health burden that affects the structure and function of large and small blood vessels and induces disease-specific end-organ damage. Exercise therapy is highly recommended in the treatment of arterial hypertension to reduce blood pressure and ameliorate hypertension-induced vascular damage. Previous exercise intervention studies have shown that exercise treatment improves vascular dysfunction independently of changes in blood pressure. Several sensitive vascular biomarkers exist that could optimize risk stratification and therapeutic decisions based on the progression of individual vascular damage in patients with arterial hypertension. However, individualized vascular assessment during anti-hypertensive treatment is not yet part of routine clinical practice. In order to improve clinical decision making from a personalized medicine perspective, it is essential to better understand which vascular biomarkers have the best sensitivity in detecting therapy-induced vascular adaptations and whether anti-hypertensive therapy with or without additional exercise improves vascular health in patients with hypertension. The proposed study will evaluate the effects of guideline-directed anti-hypertensive therapy with or without individualized exercise training intervention in 60 patients with hypertension and no previous medical treatment for one year. Regular outpatient assessments of blood pressure and large and small blood vessels will be performed every two months. Anti-hypertensive therapy will be based on the current guidelines of the European Society of Hypertension. The investigators aim to achieve the target blood pressure after six months of treatment. A further six-month follow-up is planned to assess the long-term effects of anti-hypertensive therapy, with or without additional individualized exercise training intervention, on blood pressure and macro- and microvascular health. In addition, the investigators will investigate the effect of metabolic changes induced by anti-hypertensive treatment or individualized exercise training intervention on vascular health.

Вмешательства

  • Поведенческое Individualized exercise therapy
    Patients in the intervention group will receive an individualized exercise training program 3x/week.
  • Поведенческое Lifestyle recommendations
    The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.

Первичные конечные точки

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. [Срок оценки: From enrollment to the end of treatment after six month.]
  • Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters. [Срок оценки: From enrollment to the end of treatment after six month.]
Вторичные конечные точки (12)
  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the systolic and diastolic blood pressure compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. [Срок оценки: From enrollment to the end of treatment after six month.]
  • Effect of an guideline based anti-hypertensive therapy on the systolic and diastolic blood pressure. [Срок оценки: From enrollment to the end of treatment after six month.]
  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the microvascular endothelial function compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. [Срок оценки: From enrollment to the end of treatment after six month.]
  • Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function. [Срок оценки: From enrollment to the end of treatment after six month.]
  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the arterial stiffness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. [Срок оценки: From enrollment to the end of treatment after six month.]
  • Effect of an guideline based anti-hypertensive therapy on arterial stiffness. [Срок оценки: From enrollment to the end of treatment after six month.]
  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on physical fitness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. [Срок оценки: From enrollment to the end of treatment after six month.]
  • Effect of an guideline based anti-hypertensive therapy on physical fitness. [Срок оценки: From enrollment to the end of treatment after six month.]
  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the NO metabolism of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. [Срок оценки: From enrollment to the end of treatment after six month.]
  • Effect of a guideline based anti-hypertensive therapy on the NO metabolism of stored blood samples. [Срок оценки: From enrollment to the end of treatment after six month.]
  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the metabolic profile of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. [Срок оценки: From enrollment to the end of treatment after six month.]
  • Effect of a guideline based anti-hypertensive therapy on the metabolic profile of stored blood samples. [Срок оценки: From enrollment to the end of treatment after six month.]

Критерии участия

Критерии включения

\- systolic hypertension grade I-II (BP values >140 mmHg to <180 mmHg) without anti-hypertensive medication treatment

Критерии исключения

  • no written informed consent
  • age <18 years
  • isolated diastolic hypertension
  • medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test)
  • chronic eye diseases on both eyes (for example macular degeneration or glaucoma) or high intraocular pressure (>20 mmHg)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Германия · 1 центр
  • Universitätsklinik Düsseldorf — Düsseldorf

Идентификаторы

NCT: NCT06823570 · 2023-2603

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗