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Clinical Trials/NCT03986892
NCT03986892
Completed
Not Applicable

Functional Aging in Health and Heart Failure: The COmPLETE Study

Arno Schmidt-Trucksäss1 site in 1 country678 target enrollmentJanuary 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Arno Schmidt-Trucksäss
Enrollment
678
Locations
1
Primary Endpoint
Cardiorespiratroy Fitness
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2018
End Date
January 31, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Arno Schmidt-Trucksäss
Responsible Party
Sponsor Investigator
Principal Investigator

Arno Schmidt-Trucksäss

Prof. Dr. med.

University of Basel

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cardiorespiratroy Fitness

Time Frame: 3 hours after inclusion in study

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

Ventilatory Efficiency

Time Frame: 3 hours after inclusion in study

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

Arterial stiffness

Time Frame: 0.5 hours after inclusion in study

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

Endothelial function

Time Frame: 1 hours after inclusion in study

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

Carotid-intima-media thickness

Time Frame: 1 hour after inclusion in study

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

Oxygen Uptake Efficiency

Time Frame: 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

Time Frame: 1.5 hours after inclusion in study

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

Hand grip strength

Time Frame: 2.5 hours after inclusion in study

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

Standing balance

Time Frame: 2.5 hours after inclusion in study

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

Retinal arterial and venous diameters

Time Frame: 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

Time Frame: 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

Time Frame: 1 hour after inclusion in study

Meausred by echocardiography reported as %.

Retinal endothelial function

Time Frame: 7-30 days after inclusion in study

Measured by dynamic retinal vessel analysis reported as %.

Study Sites (1)

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