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Completed

NCT Number: NCT03986892

The COmPLETE Study

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.

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Key information

Conditions

Aging Behavior Cardiovascular Diseases Heart Diseases Heart Failure Motor Activity

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel

Basel, 4052, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

C-Health:

  • Healthy men and women aged 20-100 years
  • Body mass index < 30 kg/m2
  • Nonsmoker

C-Heart:

  • Stable CHF (treated patient with symptoms and signs that have remained generally unchanged for at least one month) characterized according to the European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure [82], as follows:
  • HFrEF (LVEF < 40%)
  • HFmHF (LVEF 40-49%)
  • HFpEF (LVEF ≥ 50%) and NT-proBNP > 125 pg/mL and structural or functional changes in echocardiography in no. 2 or 3.

Exclusion criteria

C-Health:

  • Age younger than 20 years; manifest exercise limiting chronic disease (e.g., myocardial infarction; stroke; heart failure; lower-extremity artery disease; cancer with general symptoms; diabetes; clinically apparent renal failure; severe liver disease; chronic bronchitis GOLD stages II to IV; osteoporosis), women with known pregnancy or breastfeeding; drug or alcohol abuse; hypertonic blood pressure of less than 160/100 mmHg; compromising orthopaedic problems; Alzheimer's disease or any other form of dementia; inability to follow the procedures of the study (e.g., due to language problems, psychological disorders, dementia of the participant); diseases regarded as an absolute contraindication for maximal exertion; and current or past smoking status.

C-Heart:

  • Age younger than 20 years; women with known pregnancy or breastfeeding; drug or alcohol abuse; inability to follow the study procedures (e.g., due to language problems, psychological disorders, etc.); unstable angina pectoris; uncontrolled brady- or tachyarrythmia; paroxysmal atrial fibrillation; severe uncorrected valvular disease; acute myocardial infarction or coronary syndrome; transient ischemic attack or stroke occurring less than three months prior; clinically significant concomitant disease states (e.g. uncontrolled hypertonic blood pressure); clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin and/or cervical intraepithelial neoplasia; currently receiving systemic chemotherapy and/or radiotherapy; significant musculoskeletal disease other than that associated with heart failure limiting exercise tolerance; active infection; immunosuppressive medical therapy; life-expectancy of less than six months; and prevalence of a disease regarded as an absolute contraindication for maximal exertion.

Treatment and study plan

Physical activity

Behavioral

Physical Activity

Primary outcomes

  1. Cardiorespiratroy Fitness

    Time frame: 3 hours after inclusion in study

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

  2. Ventilatory Efficiency

    Time frame: 3 hours after inclusion in study

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

  3. 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.

  4. Gait speed

    Time frame: 1.5 hours after inclusion in study

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

  5. Standing balance

    Time frame: 2.5 hours after inclusion in study

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

  6. Hand grip strength

    Time frame: 2.5 hours after inclusion in study

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

  7. 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

  8. 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).

  9. Endothelial function

    Time frame: 1 hours after inclusion in study

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

  10. Left ventricular ejection fraction

    Time frame: 1 hour after inclusion in study

    Meausred by echocardiography reported as %.

  11. Carotid-intima-media thickness

    Time frame: 1 hour after inclusion in study

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

  12. 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.

  13. Retinal endothelial function

    Time frame: 7-30 days after inclusion in study

    Measured by dynamic retinal vessel analysis reported as %.

Sponsors and collaborators

Lead sponsor

Arno Schmidt-Trucksäss

Other

Registry information

Official study title

Functional Aging in Health and Heart Failure: The COmPLETE Study

Acronym: COmPLETE

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 14, 2019
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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