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OpenTrials
Completed

NCT Number: NCT06939205

Body Surface Area Prediction Impacts on Ventricular Dilatation Prevalence

The goals of this observational study are to investigate the accuracy of different predictive equations for body surface area (BSA) estimation and to evaluate the impact of different BSA normalizations on ventricular dilatation prevalence in youth soccer players. Two convenience samples of young soccer players of both genders will be recruited. Acquisition of optical images (for the players of the first sample), two-dimensional echocardiographic assessment (for the players of the second sample), and weight and height measurements (for the players of both samples) will be performed. BSA estimates will be derived from optical images (for the players of the first sample) and from ten different predictive equations obtained from the literature (for the players of both samples). Comparisons between optical imaging - derived BSA and BSA estimates obtained with the ten predictive equations will be performed for the players of the first sample. Absolute and relative values of different echocardiographic variables will be considered for the players of the second sample to assess the ventricular dilatation prevalence.

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Key information

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Turin

Torino, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy subjects
  • regular sports participation

Exclusion criteria

  • athletic heart syndrome

Treatment and study plan

Assessment of body surface area and assessment ventricular dilatation prevalence

Diagnostic Test

Estimation of body surface area and quantification of absolute and relative values of echocardiographic variables

Primary outcomes

  1. Body surface area (BSA)

    Time frame: Baseline (preseason investigation)

    Estimation of the BSA value: weight (unit of measurement: kg) and height (unit of measurement: m) will be combined to report BSA in m^2

  2. Left ventricular dilatation prevalence

    Time frame: Baseline (preseason investigation)

    Absolute and relative (normalized to body surface area - BSA) values of the following echocardiographic variables will be considered:

    • left ventricular end-diastolic diameter (LVEDD: absolute value in mm; relative value in mm/m^2); 2) left ventricular end diastolic volume (LVEDV: absolute value in ml; relative value in ml/m^2).

    The left ventricular dilatation will be identified if one or both the relative variables are above the following cut-points: i) LVEDD: 30 mm/m^2 for males and 31 mm/m^2 for females; ii) LVEDV: 74 ml/m^2 for males and 61 ml/m^2 for females.

  3. Right ventricular dilatation prevalence

    Time frame: Baseline (preseason investigation)

    Absolute and relative (normalized to body surface area - BSA) values of the fright ventricular basal diameter (RVBD: absolute value in mm; relative value in mm/m^2) will be considered.

    The right ventricular dilatation will be identified if RVBD is above the cut-point of 22 mm/m^2 for both males and females

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

The Impact of Different Body Surface Area Prediction Equations on Ventricular Dilatation Prevalence in Youth Soccer Players

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

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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