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Trial record 1 of 1 for:    NCT02568072
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Training-induced Increased Left Ventricular Trabeculation (MARATHON)

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ClinicalTrials.gov Identifier: NCT02568072
Recruitment Status : Completed
First Posted : October 5, 2015
Results First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Collaborators:
St. Bartholomew's Hospital
Cardiac Risk in the Young
British Heart Foundation
Information provided by (Responsible Party):
St George's, University of London

Brief Summary:
This project will expand on research conducted by the investigators' group, where the investigators have demonstrated increased LV trabeculation, satisfying currently existing criteria for LV Non-Compaction Cardiomyopathy (LVNC), in groups exposed to high cardiac workloads. To the investigators' knowledge, this will be the first prospective study aiming to demonstrate a direct relationship between high levels of exercise and increased LV trabeculation. This study may add weight to the theory that this entity currently described as LVNC, is a morphological epiphenomenon common to many distinct myocardial remodeling processes associated with increased cardiac preload and afterload and may better define normal adaptive increases in LV trabeculation.

Condition or disease
Athletes Heart Left Ventricular Hypertrabeculation

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Increased Left Ventricular Trabeculation in Athletes - a Marker of Left Ventricular Non-compaction or a Physiological Epiphenomenon of Increased Cardiac Preload?
Study Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016





Primary Outcome Measures :
  1. Thickness of Compacted Myocardial Tissue (cm) [ Time Frame: Baseline and 7 months ]

    Measured on echocardiography and cardiac magnetic resonance:

    1. Echocardiographic measure of compacted myocardial tissue (systole) - Jenni Compacted layer measurement (cm)
    2. Cardiac magnetic resonance measure of compacted myocardial tissue (diastole) - Petersen Compacted layer measurement (cm)

  2. Thickness of Non-compacted Myocardial Tissue (cm) [ Time Frame: Baseline and 7 months ]

    Measured on echocardiography and cardiac magnetic resonance:

    1. Echocardiographic measure of non-compacted myocardial tissue (systole) - Jenni Non-Compacted layer measurement (cm)
    2. Cardiac magnetic resonance measure of non-compacted myocardial tissue (diastole) - Petersen Non-Compacted layer measurement (cm)

  3. Myocardial Fractal Dimension [ Time Frame: Baseline and 7 months ]

    Measured on cardiac magnetic resonance, dimensionless unit and measure of endomyocardial boarder complexity. The higher the value the greater the endocardial boarder complexity and therefore the more trabeculation.

    Two measurements were made:

    1. Captur et al. Global mean left ventricular fractal dimension
    2. Captur et al. Maximum apical fractal dimension

    These values are between 1 and 2. Binarisation eliminates pixel detail originating from the blood pool. The edge image is covered by a series of grids. The minimum size is set to 2 pixels. The maximum size of the grid series is dictated by the dimensions of the bounding box, referring to the smallest rectangle that encloses the foreground pixels. Through the implementation of this 2D box-counting approach, a fractal output of between 1 and 2 is expected. The log-lot plot (e) produces a good fit using linear regression and yields a gradient equivalent to - FD (1.363).



Secondary Outcome Measures :
  1. Increase in Peak Oxygen Consumption on Cardiopulmonary Exercise Testing After Training [ Time Frame: Baseline and 7 months ]
    peak oxygen consumption measured by cardiopulmonary exercise testing on a semi-recumbent cycle ergometer. Reported standardised to age, gender, height and weight in ml/kg/min


Other Outcome Measures:
  1. Change in NTproBNP Levels [ Time Frame: Baseline and 7 months ]

    Serum biomarker level.

    No outcome data reported as during the conduct of the study remodelling was not seen from baseline to post-marathon study time-points and therefore NTproBNP levels were expected to remain unchanged and would not provide any additional value in the study and so was not undertaken.



Biospecimen Retention:   Samples With DNA
Blood samples. Urine samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy participants running first marathon event in Virgin London Marathon 2016.
Criteria

Inclusion Criteria:

1. Asymptomatic and normotensive sedentary individuals (≤2 hours/week of physical activity) aged 18-35 years

Exclusion Criteria:

  1. Hypertension;
  2. Previous cardiac history;
  3. Symptoms suggestive of cardiac disease;
  4. Use of anabolic steroids;
  5. Use of performance enhancing drugs;
  6. Abnormal ECG (As defined by the proposed refined ECG screening criteria for black and white athletes published by the Investigators' group)
  7. Left ventricular hypertrophy >15 mm in males and >12 mm in females;
  8. Significant valvular heart disease or intra-cardiac shunt on echocardiography
  9. Individuals with contraindications to cardiac MRI scanning
  10. Pregnant or breastfeeding women.

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): NCT02568072


Locations
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United Kingdom
Barts Heart Centre
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
St George's, University of London
St. Bartholomew's Hospital
Cardiac Risk in the Young
British Heart Foundation
Investigators
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Principal Investigator: Sanjay Sharma, MD FRCP FESC St George's, University of London
Additional Information:
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02568072    
Other Study ID Numbers: 15.0035
FS/15/27/31465 ( Other Grant/Funding Number: British Heart Foundation )
First Posted: October 5, 2015    Key Record Dates
Results First Posted: August 5, 2021
Last Update Posted: August 5, 2021
Last Verified: July 2021
Keywords provided by St George's, University of London:
exercise
cardiac remodelling
left ventricular non-compaction cardiomyopathy