Semmelweis Sport Study

NCT ID: NCT03025737

Last Updated: 2017-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Athletes Heart

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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athletes

Healthy highly trained elite athletes, recreational athletes, young and master athletes free of known structural myocardial disease

No interventions assigned to this group

controls

Healthy volunteers without a history of competitive physical exercise

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research, Development and Innovation Office (NKFIH) of Hungary (K 120277).

UNKNOWN

Sponsor Role collaborator

Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role lead

Responsible Party

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Bela Merkely

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heart and Vascular Center, Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Hajnalka Vágó, MD, PhD

Role: CONTACT

+36208258058

Orsolya Kiss, MD, PhD

Role: CONTACT

+36208258029

Facility Contacts

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Lilla Halász

Role: primary

+36206632509

Other Identifiers

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Semmelweis Sport

Identifier Type: -

Identifier Source: org_study_id

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