NCT01305304

Brief Summary

Until now it has been assumed that regular endurance training has a positive influence on cardiac function and that the positive effect increases with increasing intensity. However, little is known about the effects of intense endurance stress on the heart. According to current knowledge repeated exposure to strenuous endurance activity may lead to minor but possibly irreversible damage to the heart with resultant scarring of the heart's muscle. Within this study the investigators attempt to find out by different analytical methods - in particular magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the heart muscle is affected by long term intense endurance exercise and which changes in cardiac function and morphology can possibly be found. Therefore the investigators compare former national competitive endurance athletes with sedentary controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

February 11, 2011

Last Update Submit

May 14, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • cardiac fibrosis (area in cm^2) on late contrast enhanced MR images

    at subject enrollment (cross-sectional design)

Secondary Outcomes (7)

  • systolic/diastolic function and contractility measured by echocardiography

    at subject enrollment (cross-sectional design)

  • various parameters of cardiac function and morphology assessed with MRI and echocardiography

    at subject enrollment (cross-sectional design)

  • anthropometric data

    at subject enrollment (cross-sectional design)

  • VO2max

    at subject enrollment (cross-sectional design)

  • resting-ECG

    at subject enrollment (cross-sectional design)

  • +2 more secondary outcomes

Study Arms (2)

1

15 healthy male "veteran" runners (marathon, triathlon, orienteering) aged between 40 and 65 years with a history of competitive running at a national level during a period of at least 5 years, implicating normally a runner career with at least 50km per week over more than 10 years

Other: repeated long term endurance exercise

2

15 healthy male volunteers, matched for age and bmi, without a history of competitive physical exercise (i.e. sedentary controls)

Other: Other

Interventions

competitive running at a national level during a period of at least 5 years (i.e. approximately 50km per week over more than 10 years)

1
OtherOTHER

No history of endurance sports activity

2

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

residents of Switzerland, either with history of national competitive endurance running (cases) or without history of endurance running (controls)

You may qualify if:

  • Age 40-65y
  • Healthy
  • history of national competitive endurance running (cases)
  • no history of endurance running (controls)

You may not qualify if:

  • Contraindication for MRI
  • History of relevant cardiac disease (including cardiomyopathies)
  • coronary heart disease
  • coronary abnormalities
  • cardiovascular risk factors
  • History of any chronic disease
  • drug abuse
  • Arrhythmias which make adequate echocardiography unfeasible (such as atrial fibrillation or bundle-branch blocks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern

Bern, CH-3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Myocardial IschemiaMyocardial InfarctionVentricular Remodeling

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Study Officials

  • Michael Ith, PhD, PhD/MD

    Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern

    PRINCIPAL INVESTIGATOR
  • Christoph Stettler, MD

    Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 28, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

July 1, 2012

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations