Semmelweis Sport Study

Athletes Heart Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03025737
• Other study ID #: Semmelweis Sport
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2017
• Last updated: January 18, 2017
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: January 2017
• Source: Semmelweis University Heart and Vascular Center
• Contact: Hajnalka Vágó, MD, PhD
• Phone: +36208258058
• Email: vagoha[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Athletes Heart

Locations

Country	Name	City	State
Hungary	Heart and Vascular Center, Semmelweis University	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center	National Research, Development and Innovation Office (NKFIH) of Hungary (K 120277).

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary analysis will be an investigation regarding the athletic adaptation using CMR		Baseline
Secondary	The primary analysis will be an investigation regarding the athletic adaptation using cardiopulmonary exercise testing		Baseline
Secondary	The primary analysis will be an investigation regarding the athletic adaptation using resting ECG		Baseline
Secondary	The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG		Baseline