Semmelweis Sport Study

January 18, 2017 updated by: Bela Merkely, Semmelweis University Heart and Vascular Center

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Heart and Vascular Center, Semmelweis University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elite, recreational, young and master athletes Healthy volunteers without a history of competitive physical exercise

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
athletes
Healthy highly trained elite athletes, recreational athletes, young and master athletes free of known structural myocardial disease
controls
Healthy volunteers without a history of competitive physical exercise

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Semmelweis Sport

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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