Trial record 2 of 234797 for:    ALL

Semmelweis Sport Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Semmelweis University Heart and Vascular Center
Sponsor:
Collaborator:
National Research, Development and Innovation Office (NKFIH) of Hungary (K 120277).
Information provided by (Responsible Party):
Bela Merkely, Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier:
NCT03025737
First received: January 12, 2017
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
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.

Condition
Athletes Heart

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Semmelweis Sport - Complex Cardiovascular Screening of Elite, Recreational, Young and Master Athletes

Further study details as provided by Semmelweis University Heart and Vascular Center:

Primary Outcome Measures:
  • The primary analysis will be an investigation regarding the athletic adaptation using CMR [ Time Frame: Baseline ]

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

Biospecimen Retention:   Samples With DNA
Samples with DNA, serum, plasma

Estimated Enrollment: 150
Study Start Date: January 2017
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elite, recreational, young and master athletes Healthy volunteers without a history of competitive physical exercise
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03025737

Contacts
Contact: Hajnalka Vágó, MD, PhD +36208258058 vagoha@gmail.com
Contact: Orsolya Kiss, MD, PhD +36208258029 dr.orsolya.kiss@gmail.com

Locations
Hungary
Heart and Vascular Center, Semmelweis University Recruiting
Budapest, Hungary, 1122
Contact: Lilla Halász    +36206632509    merkely.study@gmail.com   
Sponsors and Collaborators
Semmelweis University Heart and Vascular Center
National Research, Development and Innovation Office (NKFIH) of Hungary (K 120277).
  More Information

Responsible Party: Bela Merkely, Principal Investigator, Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier: NCT03025737     History of Changes
Other Study ID Numbers: Semmelweis Sport 
Study First Received: January 12, 2017
Last Updated: January 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Semmelweis University Heart and Vascular Center:
Hypertrophy, Left Ventricular
Ventricular Remodeling

ClinicalTrials.gov processed this record on January 19, 2017