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临床试验/NCT03986892
NCT03986892已完成不适用

Functional Aging in Health and Heart Failure: The COmPLETE Study

Arno Schmidt-Trucksäss1 个研究点 分布在 1 个国家目标入组 678 人开始时间: 2018年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
678
试验地点
1
主要终点
Cardiorespiratroy Fitness

研究概览

简要总结

The project is designed as a large scale, cross-sectional study. This research seeks to identify physical fitness and cardiovascular parameters that best resemble underlying cardiovascular risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure.

详细描述

Cardiovascular (CV) diseases including heart failure are the leading causes of morbidity, with age being the primary risk factor. The combination of age-related organic functional impairment and reduced physical fitness can drastically impact an individual's healthspan. One's lifespan can potentially be prolonged by the preservation or improvement of physical fitness. However, it remains unclear as to which biomarkers are most suitable for distinguishing between healthy aging and the impaired organ function associated with heart failure. Therefore, a comprehensive assessment of the components of physical fitness and CV function will be performed to identify the most important factors contributing to aging in relation to both health and disease.

This cross-sectional investigation will consist of two parts: the COmPLETE-Health (C-Health) and COmPLETE-Heart (C-Heart) studies. C-Health will examine the aging trajectories of physical fitness components and CV properties in a healthy population sample aged between 20 and 100 years (n = 490). Separately, C-Heart will assess the same markers in patients at different stages of chronic heart failure (n = 80). The primary outcome to determine the difference between C-Health and C-Heart will be cardiorespiratory fitness as measured by cardiopulmonary exercise testing on a bicycle ergometer. Secondary outcomes will include walking speed, balance, isometric strength, peak power, and handgrip strength. Physical activity as a behavioural component will be assessed objectively via accelerometry. Further, CV assessments will include pulse wave velocity; retinal, arterial, and venous diameters; brachial and retinal arterial endothelial function; carotid intima-media thickness; and systolic and diastolic function. The health distances for C-Health and C-Heart will be calculated using the methodology based on statistical (Mahalanobis) distance applied to measurements of quantitative biomarkers.

This research seeks to identify physical fitness and CV biomarkers that best resemble underlying CV risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure. The presented integrative approach could define new recommendations for diagnostic guidance in aging. Ultimately, this study is expected to offer a better understanding of which functional characteristics should be specifically targeted in primary and secondary prevention to achieve an optimal healthspan.

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
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cardiorespiratroy Fitness

时间窗: 3 hours after inclusion in study

Maximal Oxygen uptake measured by cardiopulmonary exercise testing (VO2peak) in L/min

Ventilatory Efficiency

时间窗: 3 hours after inclusion in study

VE/VCO2 measured by cardiopulmonary exercise testing ((L/min)/(L/min))

Arterial stiffness

时间窗: 0.5 hours after inclusion in study

Meausred by an noninvasive vascular screening system. Reported as brachial-ankle pulse wave velocity (baPWV).

Endothelial function

时间窗: 1 hours after inclusion in study

Meausred as flow mediated dilation (FMD) by ultrasound reported as %.

Carotid-intima-media thickness

时间窗: 1 hour after inclusion in study

Carotid intima-media thickness (mm) is measured by 2D ultrasound instrument.

Oxygen Uptake Efficiency

时间窗: 3 hours after inclusion in study

The Oxygen Uptake Efficiency Slope is defined as the regression slope 'a' in V̇O2 = a × log VE +b measured by cardiopulmonary exercise testing.

Gait speed

时间窗: 1.5 hours after inclusion in study

Gait speed measured by an inertial sensor system in m/s.

Hand grip strength

时间窗: 2.5 hours after inclusion in study

Measured by a handheld dynamometer. Maximal achieved grip strength (kg) is recorded.

Standing balance

时间窗: 2.5 hours after inclusion in study

The cumulative sway path (cm) serves as a measure of postural control.

Retinal arterial and venous diameters

时间窗: 7-30 days after inclusion in study

Measured by static retinal vessel analysis. Diameters will be averaged to central retinal arteriolar and venular equivalents (CRAE and CRVE) and the arteriolar-to-venular diameter ratio will be calculated from the CRAE and CRVE.

Power of leg muscles

时间窗: 2.5 hours after inclusion in study

Peak power measured by countermovement jump performed on a force plate. Reported in N/kg

Left ventricular ejection fraction

时间窗: 1 hour after inclusion in study

Meausred by echocardiography reported as %.

Retinal endothelial function

时间窗: 7-30 days after inclusion in study

Measured by dynamic retinal vessel analysis reported as %.

次要结局

未报告次要终点

研究者

发起方
Arno Schmidt-Trucksäss
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arno Schmidt-Trucksäss

Prof. Dr. med.

University of Basel

研究点 (1)

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