CardiomyopathiesNCT06939205
Body Surface Area Prediction Impacts on Ventricular Dilatation Prevalence
An observational study of Cardiomyopathies, run by University of Turin, Italy at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- Assessment of body surface area and assessment ventricular dilatation prevalence
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Soccer players of both genders
Who may be able to join
- healthy subjects
- regular sports participation
Who cannot join
- athletic heart syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Different Body Surface Area Prediction Equations on Ventricular Dilatation Prevalence in Youth Soccer Players
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.
- Conditions
- Cardiomyopathies
- Being tested
- Assessment of body surface area and assessment ventricular dilatation prevalence
- Keywords
- 3-D optical imaging, Body surface area, soccer, transthoracic echocardiography
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of body surface area and assessment ventricular dilatation prevalenceDiagnostic test
Estimation of body surface area and quantification of absolute and relative values of echocardiographic variables
What is being measured
The primary outcome is the main question the study is designed to answer.
Body surface area (BSA)
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
Measured: Baseline (preseason investigation)
Left ventricular dilatation prevalence
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.
Measured: Baseline (preseason investigation)
Right ventricular dilatation prevalence
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
Measured: Baseline (preseason investigation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Dec 2023
- Primary completion31 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Alessandro Minetto, University of Turin, Italy
- Investigators
- Marco Alessandro Minetto, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939205
- Sponsor's protocol ID
- UniTO&JMedBSAstudy
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Body Surface Area Prediction Equations on Ventricular Dilatation Prevalence in Youth Soccer Players
- ClinicalTrials.gov ID
- NCT06939205
- Acronym / sponsor ID
- UniTO&JMedBSAstudy
- Conditions
- Cardiomyopathies
- Keywords
- 3-D optical imaging, Body surface area, soccer, transthoracic echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Soccer players of both genders
Key inclusion criteria (2 listed)
- healthy subjects
- regular sports participation
Key exclusion criteria (1 listed)
- athletic heart syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of body surface area and assessment ventricular dilatation prevalenceEstimation of body surface area and quantification of absolute and relative values of echocardiographic variables | Diagnostic test | – |
Primary outcome
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
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: 1) 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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Alessandro Minetto principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body surface area (BSA) (time frame: Baseline (preseason investigation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.