Semmelweis Sport Study

• Conditions: Athletes Heart

• Registration Number: NCT03025737
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Study First Posted: 2017-01-19
• Last Update Posted: 2017-01-19
• Primary Completion: 2018-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary analysis will be an investigation regarding the athletic adaptation using CMR	Baseline

Secondary Outcome Measures

Name	Time	Method
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 24-Hour Holter ECG	Baseline
The primary analysis will be an investigation regarding the athletic adaptation using resting ECG	Baseline

Trial Locations

Locations (1)

Heart and Vascular Center, Semmelweis University; 🇭🇺 Budapest, Hungary