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Sudden Cardiac DeathNCT07862504

Cardiovascular Pre-participation Screening in Children and Adolescents

An observational study of Sudden Cardiac Death and Cardiac Arrhythmias, run by University of Sao Paulo at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Sports participation is strongly encouraged in children and adolescents, but intense training at early ages may reveal hidden heart conditions that increase the risk of sudden cardiac death. Pre-participation evaluation aims to identify these conditions before sports practice. Read more about this study

Who is it for?
Ages 5 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Sudden Cardiac Death, Cardiac Arrhythmias
What is being tested?
Pre-participation clinical evaluation, Diagnostic Test: Resting 12-lead electrocardiogram and Diagnostic Test: Step test (Harvard step test)
How many people
334 participants
Where
1 siteBrazil
Study dates
Feb 2027to 22 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 5 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children and adolescents younger than 18 years regularly enrolled in organized sports in the São Paulo Olympic Program, with at least two training sessions per week, evaluated at the Heart Institute (InCor), São Paulo, Brazil.

Who may be able to join

  • Age under 18 years
  • Regular enrollment in organized sports in the São Paulo Olympic Program, with at least two training sessions per week
  • Informed consent signed by the legal guardian and assent signed by the participant
  • Availability to complete all study procedures (medical history, physical examination and resting electrocardiogram)

Who cannot join

  • Inability to understand the study procedures
  • Refusal to participate by the legal guardian or the participant
  • Acute febrile illness in the 72 hours before data collection
  • Known structural heart disease under follow-up without medical clearance for sports practice
  • Previous abnormal electrocardiogram under active investigation
  • Known pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Savia Bueno, MD, PhD contact

51126615341

savia_bueno@hotmail.com

Brazil1 site
  • Heart Institute

    São Paulo, São Paulo

    Savia Bueno, MD, PhD, 51126615341, savia_bueno@hotmail.com

Other trials in Brazil

About this study

Official title: Cardiovascular Pre-participation Evaluation With Physical Examination, Resting Electrocardiogram and Step Test in Children and Adolescents of the São Paulo Olympic Program: a Prospective Observational Study

Sports participation is strongly encouraged in children and adolescents, but intense training at early ages may reveal hidden heart conditions that increase the risk of sudden cardiac death. Pre-participation evaluation aims to identify these conditions before sports practice.

This observational study will evaluate children and adolescents enrolled in the São Paulo Olympic Program (Programa São Paulo Olímpico). All participants will undergo a structured medical interview, a standardized physical examination and a resting 12-lead electrocardiogram (ECG). Participants with borderline ECG findings, warning symptoms, abnormal physical examination findings or a suggestive personal or family history will also undergo a 3-minute step test (Harvard step test) with continuous ECG recording during exercise and recovery, in order to detect exercise-induced arrhythmias.

The main goal is to estimate the prevalence of potentially pathological ECG findings in this population. The study will also describe warning signs in the medical history, abnormal physical examination findings, step test results, and the referrals and confirmed diagnoses during follow-up.

Read the detailed description

Background

Sports practice in childhood and adolescence brings physical, psychological and social benefits. However, the cardiovascular demands of exercise may reveal or worsen latent conditions that, if unrecognized, can lead to adverse events, including sudden cardiac death (SCD). Pre-participation evaluation (PPE) is a screening tool designed to detect such conditions and usually includes medical and family history, physical examination and, in some protocols, a resting electrocardiogram (ECG). The ECG increases the sensitivity for arrhythmogenic cardiomyopathies, channelopathies and other electrical abnormalities that may be missed by clinical examination alone. Its routine use in minors remains controversial: European recommendations support routine ECG in young athletes, while North American organizations recommend a selective approach. There is limited evidence on the effectiveness and applicability of these protocols in pediatric populations.

Exercise-induced arrhythmias may not be detected on a resting ECG. A recent clinical consensus statement of the European Association of Preventive Cardiology (EAPC) and the Association for European Paediatric and Congenital Cardiology (AEPC) considers a continuous 3-minute step test with ECG recording during exercise and after abrupt cessation, followed by 3 minutes of post-exercise monitoring, a valid, low-cost and widely available alternative to rule out exercise-induced arrhythmias in pediatric athletes.

Study design and setting

Prospective observational study conducted at the Heart Institute (Instituto do Coração, InCor), Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, Brazil, including children and adolescents enrolled in organized sports in the São Paulo Olympic Program.

Procedures

  1. Screening and registration: eligibility check and collection of sociodemographic data (age, sex, self-reported race/skin color), sport, training load (hours per week) and competitive level.
  2. Structured medical history: standardized pediatric cardiovascular risk questionnaire applied by trained interviewers, covering symptoms (exertional syncope or near-syncope, exertional chest pain, disproportionate dyspnea, palpitations), personal history (asthma, use of stimulants or supplements, previous moderate or severe coronavirus disease 2019 [COVID-19], hospitalizations), family history (sudden death before 50 years of age, inherited cardiomyopathies, channelopathies, Marfan syndrome, premature coronary artery disease) and sports history (adverse events during training or competition, interruptions due to symptoms).
  3. Standardized physical examination: blood pressure (appropriate cuff size, mean of two seated measurements), heart rate, oxygen saturation, weight, height, body mass index (BMI) and optional Tanner pubertal staging; cardiovascular examination including inspection, palpation of the precordium and pulses (including femoral pulses), auscultation in supine and standing positions, Valsalva maneuver when indicated; assessment of Marfan phenotype.
  4. Resting 12-lead ECG: calibrated digital equipment (25 mm/s; 10 mm/mV), supine position, after 5 minutes of rest and no caffeine or stimulants in the previous 12 hours. Tracings will be independently analyzed by two cardiologists experienced in sports cardiology, blinded to clinical data. Disagreements will be resolved by consensus or by a third reader. Recorded variables include rhythm, heart rate, electrical axis, PR, QRS and QT intervals, corrected QT interval (QTc), voltages, repolarization, chamber enlargement criteria, pre-excitation, bundle branch and atrioventricular (AV) blocks, T and J waves, and classification as normal athlete-related or potentially pathological according to the study's operational classification.
  5. Step test (second-tier evaluation): performed in participants with any of the following: borderline ECG findings (abnormal axis deviation, atrial enlargement, first-degree AV block with PR 200-280 ms, complete right bundle branch block, borderline T-wave inversion in V1-V4 at ages 12-14 years, low QRS voltage, Mobitz type I second-degree AV block); warning symptoms (exertional syncope or near-syncope, palpitations during or after exercise, disproportionate dyspnea, exertional chest pain); abnormal physical examination (heart murmur grade 2/6 or higher, arrhythmia on auscultation, elevated blood pressure or abnormal pressure response); or suggestive history (family history of sudden cardiac death before 50 years of age, previous myocarditis, family history of long or short QT syndrome). Step test protocol: fixed-height step of 45 cm (30 cm for children younger than 12 years). After a supine baseline ECG, the test includes 1 minute of seated rest with continuous 12-lead ECG; 3 minutes of continuous stepping at a standardized cadence with continuous ECG recording; abrupt cessation with the participant seated and continuous 12-lead ECG during the first 3 minutes of recovery; and 3 to 5 additional minutes of monitoring with final clinical examination. Heart rate, rhythm, ST segment, T wave, QTc, symptoms, blood pressure and oxygen saturation will be recorded. The test will not be performed in the presence of fever or acute symptoms in the previous 72 hours, recent confirmed or suspected myocarditis (within 3-6 months), unexplained syncope in the previous week, known severe structural heart disease without cardiologist clearance, resting heart rate above 120 bpm or elevated resting blood pressure, clinical instability or chest pain at rest, known pregnancy, or refusal by the participant or legal guardian. The test will be stopped immediately in case of chest pain, syncope, evident intolerance or significant ECG changes. Results will be classified as normal, borderline or abnormal. The test will be supervised by a physician (cardiologist or trained pediatrician) with an ECG technician, in a clinical setting with basic life support available.
  6. Clinical management: participants with potentially pathological findings, abnormal step test results or warning symptoms will be temporarily withdrawn from competitive sports and referred for specialized evaluation (echocardiography, exercise testing, Holter monitoring, cardiac magnetic resonance imaging or genetic testing), with formal communication to legal guardians and to the sports institution. Borderline step test results will be referred for formal exercise testing or echocardiography before sports clearance.

Quality control

Training of the study team, a pilot with 20-30 athletes (including 5-10 step tests), random re-evaluation of 10% of ECGs and clinical forms, and calculation of interobserver agreement (kappa) for ECG categories.

Statistical analysis

Continuous variables will be described as mean and standard deviation or median and interquartile range, and categorical variables as frequencies and percentages. Prevalence will be estimated with 95% confidence intervals (CI). Comparisons will use chi-square or Fisher's exact test for categorical variables and Student's t test or Mann-Whitney test for continuous variables, according to distribution (Shapiro-Wilk test). Multivariable logistic regression will identify factors associated with potentially pathological findings, adjusted for age, sex, sport, training load and pubertal stage when available. Missing data will be addressed by sensitivity analysis, with multiple imputation if more than 5% of key covariates are missing. Significance level: alpha = 0.05 (two-tailed). Additional analyses for the step test include the proportion of indicated versus performed tests, prevalence of abnormal results, agreement between resting ECG and step test findings (kappa), correlation between type of ECG finding and step test result, and cost-effectiveness.

Sample size

Assuming a 95% confidence level, an expected arrhythmia prevalence of 3.6% and an absolute precision of 2 percentage points, the minimum sample size is 334 participants.

Being tested
Pre-participation clinical evaluation, Diagnostic Test: Resting 12-lead electrocardiogram, Diagnostic Test: Step test (Harvard step test)
Keywords
Pre-participation evaluation, Electrocardiography, Step test, Cardiovascular screening
Medical subject headings
Death, Sudden, Cardiac, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-participation clinical evaluationOther

    Structured cardiovascular medical history and standardized physical examination.

  • Diagnostic Test: Resting 12-lead electrocardiogramDiagnostic test

    Resting 12-lead electrocardiogram (ECG) analyzed independently by two blinded sports cardiologists.

  • Diagnostic Test: Step test (Harvard step test)Diagnostic test

    3-minute continuous step test with electrocardiogram (ECG) recording during exercise and recovery, performed only in participants with borderline ECG findings, warning symptoms, abnormal physical examination or suggestive personal or family history.

Study groups in NCT07862504
Study groupRoleWhat they receive
Young athletesChildren and adolescents younger than 18 years enrolled in organized sports in the São Paulo Olympic Program, undergoing cardiovascular pre-participation evaluation. Participants meeting predefined clinical or electrocardiographic criteria also undergo a step test.
Receives: Other: Pre-participation clinical evaluation; Diagnostic Test: Diagnostic Test: Resting 12-lead electrocardiogram; Diagnostic Test: Diagnostic Test: Step test (Harvard step test)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of potentially pathological findings on resting electrocardiogram

    Proportion of participants whose resting 12-lead electrocardiogram (ECG) is classified as potentially pathological by two independent sports cardiologists blinded to clinical data, according to the study's operational classification

    Measured: At the pre-participation evaluation (day 1)

Secondary outcomes (7)
  1. Prevalence of warning signs and symptoms in the medical history

    Proportion of participants reporting cardiovascular warning symptoms or a relevant personal or family history in the structured questionnaire.

    Measured: At the pre-participation evaluation (day 1)

  2. Prevalence of abnormal physical examination findings

    Proportion of participants with abnormal cardiovascular findings on standardized physical examination, including pathological murmurs, elevated blood pressure, abnormal pulses and Marfan phenotype.

    Measured: At the pre-participation evaluation (day 1)

  3. Odds ratio of potentially pathological electrocardiogram findings by age

    Odds ratio, with 95% confidence interval, for a resting 12-lead electrocardiogram (ECG) classified as potentially pathological per 1-year increase in age, estimated by multivariable logistic regression adjusted for sex, sport and training load.

    Measured: At the pre-participation evaluation (day 1)

  4. Odds ratio of potentially pathological electrocardiogram findings by sex

    Odds ratio, with 95% confidence interval, for a resting 12-lead electrocardiogram (ECG) classified as potentially pathological in male versus female participants, estimated by multivariable logistic regression adjusted for age, sport and training load.

    Measured: Up to 30 days after the pre-participation evaluation

  5. Odds ratio of potentially pathological electrocardiogram findings by sport

    Odds ratio, with 95% confidence interval, for a resting 12-lead electrocardiogram (ECG) classified as potentially pathological according to sport category, estimated by multivariable logistic regression adjusted for age, sex and training load.

    Measured: Up to 30 days after the pre-participation evaluation

  6. Odds ratio of potentially pathological electrocardiogram findings by training load

    Odds ratio, with 95% confidence interval, for a resting 12-lead electrocardiogram (ECG) classified as potentially pathological per 1-hour increase in weekly training load, estimated by multivariable logistic regression adjusted for age, sex and sport.

    Measured: Up to 6 months

  7. Rate of confirmed cardiovascular diagnoses

    Proportion of referred participants with a confirmed cardiovascular diagnosis after specialized evaluation.

    Measured: 3 to 6 months after the pre-participation evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study startFeb 2027 (estimated)
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion22 Dec 2027 (estimated)

Resources

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
Prospective
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07862504
Sponsor's protocol ID
8.754.498
Other IDs
93894325.7.0000.0068
Status last verified
Oct 2026
First submitted
1 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sudden Cardiac Death and Cardiac Arrhythmias, run by University of Sao Paulo at 1 site in Brazil.

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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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 Brazil. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Savia Bueno, MD, PhD (51126615341, savia_bueno@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of potentially pathological findings on resting electrocardiogram (time frame: At the pre-participation evaluation (day 1)). 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 15 Oct 2026.

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