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NCT00469794 Clinical Trial

The Significance of Arrhythmias in Athletes

Sudden Death Clinical Trial

— Athlete  

Official title:
The Long Term Significance of Exercise Induced Ventricular Arrhythmias in Trained Athletes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00469794
Other study ID # 50/06
Secondary ID
Status Recruiting
Phase N/A
First received May 4, 2007
Last updated May 4, 2007
Start date May 2006
Est. completion date May 2008

Study information
Verified date May 2007
Source Assaf-Harofeh Medical Center
Contact Therese Fuchs, MD
Phone 972-8-977-9730
Email therese@fuchs.org
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by an exercise test in a retrospectively evaluated athletic population.

Description:

Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The risk is increased when the athletes are engaged in competitive activities.

Ventricular premature beats (VPB’s) are a common finding in the athletic heart. In the majority of cases these arrhythmias are part of the “athlete’s heart syndrome” and do not increase the risk of sudden death in the athletes with an apparently normal heart. The data available in the literature deal with ventricular arrhythmias assessed only by 24-h ambulatory electrocardiograms.

To date, there are no guidelines concerning athletes who develop ventricular arrhythmias during a stress test. It is unclear whether they should be allowed to continue with their competitive activity or they should be denied to do so. A study looking at the long term follow-up of these athletes will help us determine whether the development of ventricular arrhythmia during a stress test imposes any risk on the athletes.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date May 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 35 Years
Eligibility Inclusion Criteria:

- Competitive athletes less than 35 YO

- Competitive athletes with ventricular arrhythmias on baseline or recovery in a stress test

- Competitive athletes with ventricular arrhythmia during exercise

Exclusion Criteria:

- Athletes who don’t meet the exclusion criteria.

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• stress test

Locations
Country Name City State
Israel Wingate Institute Netanya

Sponsors (2)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center Institute of Physical Education and Sports Sciences

Country where clinical trial is conducted

Israel, 

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