The COmPLETE Study
Condition: Aging; Heart Failure
MeSH terms: Heart Failure
Study type: Observational

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.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Physical Activity
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In C-Health, recruitment will be performed until a total number of 490 participants with a
        valid cardiopulmonary exercise test (CPET) as our primary outcome are included. All
        participants will be recruited in the area of Basel, including 35 males and 35 females per
        age category (i.e., 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80+ years of age).

        C-Heart will include 80 heart failure patients characterized according to criteria named
        below.

        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:

          1. HFrEF (LVEF < 40%)

          2. HFmHF (LVEF 40-49%)

          3. HFpEF (LVEF ≥ 50%) and NT-proBNP > 125 pg/mL and structural or functional changes in
             echocardiography in no. 2 or 3.
      
Biospecimen description: 
      Venous blood samples
    
Keywords: fitness; exercise; vascular function