Clinical trial NCT03025737: Semmelweis Sport Study
Official title: Semmelweis Sport - Complex Cardiovascular Screening of Elite, Recreational, Young and Master Athletes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Athletes Heart
Keywords: Hypertrophy, Left Ventricular
Ventricular Remodeling
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: National Research, Development and Innovation Office (NKFIH) of Hungary (K 120277).
First posted: 2017-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elite, recreational, young and master athletes Healthy volunteers without a history of competitive physical exercise

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary analysis will be an investigation regarding the athletic adaptation using CMR
timeFrame: Baseline
Secondary outcomes:
measure: The primary analysis will be an investigation regarding the athletic adaptation using cardiopulmonary exercise testing
timeFrame: Baseline
measure: The primary analysis will be an investigation regarding the athletic adaptation using resting ECG
timeFrame: Baseline
measure: The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG
timeFrame: Baseline
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Heart and Vascular Center, Semmelweis University
Study officials:
References: