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Идёт набор NCT05115890

Muscle Blood Flow Regulation in HFpEF

Без фазы С лечением HFpEF

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: Exercise training.
Кому может быть актуально
Состояния в реестре: HFpEF. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Mechanisms of Impaired Skeletal Muscle Blood Flow and Exercise Intolerance in Veterans With Heart Failure With Preserved Ejection Fraction: Efficacy of Knee Extensor Training

Обзор

Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression. This research proposal aims to elucidate mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF compared with healthy controls as well as following 8 weeks of exercise training in patients with HFpEF only.

Подробное описание

Heart failure (HF) with preserved ejection fraction (HFpEF) disproportionately afflicts Veterans and is the leading cause of hospitalization and mortality within the VA Health Care System. One chief symptom of HFpEF is severe exercise intolerance, an important predictor of quality of life, functional capacity, and mortality. In these patients, severe exercise intolerance is attributable to a disease-related loss of "peripheral vascular control," as evidenced by a marked attenuation in exercising skeletal muscle blood flow. Loss of peripheral vascular control is manifested as dysfunctions of the autonomic nervous system (ANS) and vasodilatory ability of the microvasculature, thereby restraining skeletal muscle blood flow and O2 delivery and limiting the capacity for sustained physical activity. This research proposal aims to elucidate peripheral vascular control mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF. In addition, there is some indication that aerobic exercise training may improve peripheral vascular function in HFpEF , though the mechanisms have yet to be elucidated. Thus, an additional aim of this research proposal is to evaluate peripheral vascular control mechanisms of skeletal muscle blood flow and exercise tolerance following 8 weeks of exercise training in patients with HFpEF. To test this, the initial phase will involve a cross-sectional comparison of patients with HFpEF (n=35) and age and sex-matched healthy controls (n=35), followed by an interventional phase where only patients with HFpEF will enter 8 weeks of exercise training. It is anticipated that knowledge gained will (a) improve the understanding of HFpEF pathophysiology and (b) determine the efficacy of a unique exercise training modality to restore functional capacity and exercise tolerance in patients with HFpEF.

Вмешательства

  • Другое Exercise training
    Patients with HFpEF will undergo 8 weeks of exercise training.

Первичные конечные точки

  • Six-minute walk test [Срок оценки: Change from baseline six-minute walk test distance at 8 weeks]
  • Muscle blood flow [Срок оценки: Change from baseline skeletal muscle blood flow at 8 weeks]

Критерии участия

Критерии включения

  • Age 18 years or older and able to give written informed consent
  • New York Heart Association (NYHA) functional class II or III
  • Left Ventricular Ejection Fraction (LVEF) > 50%
  • Plasma Brain Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP 400 pg/mL at enrollment

Критерии исключения

  • Prior EF of <50%.
  • NYHA Class IV or HF that cannot be stabilized on optimized pharmacotherapy
  • Acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis
  • Patients with HFpEF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction)
  • Orthopedic limitations that would prohibit knee-extensor exercise
  • Women currently taking hormone replacement therapy (HRT) will be excluded from the proposed studies due to the direct vascular effects of HRT
  • Women who are pregnant or may become pregnant, but the typical age of female patients with HFpEF will be postmenopausal
  • Current smokers

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City

Идентификаторы

NCT: NCT05115890 · F3670-W

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗