Semmelweis Sport Study

Semmelweis Sport - Complex Cardiovascular Screening of Elite, Recreational, Young and Master Athletes

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03025737

Enrollment

150

Registered

2017-01-19

Start date

2017-01-31

Completion date

2020-01-31

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athletes Heart

Keywords

Hypertrophy, Left Ventricular, Ventricular Remodeling

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
The primary analysis will be an investigation regarding the athletic adaptation using CMR	Baseline

Secondary

Measure	Time frame
The primary analysis will be an investigation regarding the athletic adaptation using cardiopulmonary exercise testing	Baseline
The primary analysis will be an investigation regarding the athletic adaptation using resting ECG	Baseline
The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG	Baseline

Countries

Hungary

Contacts

Primary ContactHajnalka Vágó, MD, PhD

vagoha@gmail.com+36208258058

Backup ContactOrsolya Kiss, MD, PhD

dr.orsolya.kiss@gmail.com+36208258029

Outcome results