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The COmPLETE Study (COmPLETE)

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ClinicalTrials.gov Identifier: NCT03986892
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Arno Schmidt-Trucksäss, University of Basel

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.

Condition or disease Intervention/treatment
Aging Heart Failure Behavioral: Physical Activity

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.


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Study Type : Observational
Estimated Enrollment : 780 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Functional Aging in Health and Heart Failure: The COmPLETE Study
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : September 13, 2019
Estimated Study Completion Date : September 13, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COmPLETE-Health
No intervention
Behavioral: Physical Activity
Physical Activity

COmPLETE-Heart
No intervention
Behavioral: Physical Activity
Physical Activity




Primary Outcome Measures :
  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 %.


Biospecimen Retention:   Samples Without DNA
Venous blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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:

    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.

      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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986892


Locations
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Switzerland
Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel Recruiting
Basel, Switzerland, 4052
Contact: Arno Schmidt-Trucksäss, Prof. Dr.    +41(0)612074740    arno.schmidt-trucksäss@unibas.ch   
Contact: Jonathan Wagner, MSc    +41(0)612074708    jonathan.wagner@unibas.ch   
Principal Investigator: Arno Schmidt-Trucksäss, Prof Dr         
Sponsors and Collaborators
Arno Schmidt-Trucksäss

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Responsible Party: Arno Schmidt-Trucksäss, Prof. Dr. med., University of Basel
ClinicalTrials.gov Identifier: NCT03986892     History of Changes
Other Study ID Numbers: 182815
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arno Schmidt-Trucksäss, University of Basel:
fitness
exercise
vascular function

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases