Semmelweis Sport Study

NCT03025737 | Unknown

• 1 other identifier: Semmelweis Sport
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Athletes Heart

Keywords

Hypertrophy, Left Ventricular; Ventricular Remodeling

Outcome Measures

Primary Outcomes (1)

• The primary analysis will be an investigation regarding the athletic adaptation using CMR

  Baseline

Secondary Outcomes (3)

• 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 resting ECG

  Baseline

• The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• age
• no known cardiovascular disease
• history of sport activity (athletes)
• no history of competitive sport (controls)

You may not qualify if:

• History of known relevant cardiac disease (including cardiomyopathies)
• Contraindication to MRI or cardiopulmonary exercise testing

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead
• National Research, Development and Innovation Office (NKFIH) of Hungary (K 120277).: collaborator

Study Sites (1)

Heart and Vascular Center, Semmelweis University

Budapest, 1122, Hungary

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA, serum, plasma

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hajnalka Vágó, MD, PhD

CONTACT

+36208258058; vagoha@gmail.com

Orsolya Kiss, MD, PhD

CONTACT

+36208258029; dr.orsolya.kiss@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 19, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: January 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)