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Semmelweis Sport Study

S

Semmelweis University

Status

Unknown

Conditions

Athletes Heart

Study type

Observational

Funder types

Other

Identifiers

NCT03025737
Semmelweis Sport

Details and patient eligibility

About

The aim of the present proposal is to investigate the development of distinct morphological, functional, biochemical and molecular aspects of short- and long-term sport-induced changes in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The main goal of our research is to deepen our knowledge on the proper differentiation between beneficial (physiological) and harmful (pathological) consequences of professional sport, thereby effectively preventing potential cardiovascular complications of athletes.

Full description

CLINICAL METHODS

  1. Sport specific questionnaire, patient history and physical examinations - In our detailed questionnaire, specific information is collected about quantity and quality of training, personal and family history and presence of sport specific and general symptoms.
  2. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters associated with physical exercise are planned to be measured, such as cardiac biomarkers.
  3. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
  4. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
  5. Detailed echocardiography
  6. Detailed CMR examination
  7. Body composition analysis - With a sophisticated bio-electrical impedance analysis, comprehensive whole body composition and hydration analysis will be performed.
  8. Cardiopulmonary exercise testing - Sport specific protocols will be used on both treadmill and bike ergometers.

Enrollment

150 estimated patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • age
  • no known cardiovascular disease
  • history of sport activity (athletes)
  • no history of competitive sport (controls)

Exclusion criteria

  • History of known relevant cardiac disease (including cardiomyopathies)
  • Contraindication to MRI or cardiopulmonary exercise testing

Trial design

150 participants in 2 patient groups

athletes
Description:
Healthy highly trained elite athletes, recreational athletes, young and master athletes free of known structural myocardial disease
controls
Description:
Healthy volunteers without a history of competitive physical exercise

Trial contacts and locations

1

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Central trial contact

Hajnalka Vágó, MD, PhD; Orsolya Kiss, MD, PhD

Data sourced from clinicaltrials.gov

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