Prospective Athlete's Heart Study (Pro@Heart)

December 7, 2021 updated by: dr. Guido Claessen, Universitaire Ziekenhuizen KU Leuven

Prospective Athlete's Heart Study: Long-term Assessment of the Determinants of Cardiac Remodelling and Its Clinical Consequences in Endurance Athletes

The Pro@Heart (Prospective Athlete's Heart) study is an international multicentre long-term prospective trial. The primary objective of the Pro@Heart study is to investigate the impact of training load (i.e. accurately evaluated in term of type, frequency, duration and intensity) and genotype on the variability of structural, functional and electrical exercise induced cardiac remodeling (EICR) in young competitive endurance athletes. The second objective is to determine how EICR, training load and genotype are associated with physical performance, health benefits and cardiac pathology (e.g. exercise-related cardiomyopathies and arrhythmias) during follow-up over several decades.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

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

Study Contact

Study Locations

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

14 years to 23 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Athletes aged 14 to 23 years recruited from elite endurance sports programs and organisations including Cycling Vlaanderen, Triatlon Vlaanderen, Belgian Cycling, Cycling Australia, Rowing Australia and Athletics Australia and from sports performance centres including Nottebohm Antwerpen, Bakala Academy Leuven and Adlon Hasselt. Volunteers recruited by means of 'word of mouth' and social media campaigns within elite endurance sporting circles. Non-athletes consist of age and gender matched university and college students recruited from Australian and Belgian universities in addition to social media campaigns.

Description

Inclusion Criteria:

  1. Males and females aged 14-23 years old

  2. Athletes competing in endurance sports at national or international level for at least 2 years. Sports include:

    1. Triathlon
    2. Cycling
    3. Distance running (≥ 1500 meters)
    4. Rowing
    5. Swimming
  3. Non athletes engaged in < 3 hours per week of physical activity

Exclusion Criteria:

  1. Medical history of cardiovascular disease
  2. Current smoker of past history of smoking
  3. Diabetes mellitus

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
Intervention / Treatment
Athletes
  1. Males and females aged 14-23 years old

  2. Athletes competing in endurance sports at national or international level for at least 2 years. Sports include:

    1. Triathlon
    2. Cycling
    3. Distance running (≥ 1500 meters)
    4. Rowing
    5. Swimming
Other: No intervention
No intervention
Non-athletes
  1. Males and females aged 14-23 years old
  2. Non athletes engaged in < 3 hours per week of physical activity
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotype
Time Frame: Baseline
Rare and common variants in cardiomyopathy associated genes
Baseline
Training load
Time Frame: Baseline to 20 years
Duration and intensity of training
Baseline to 20 years
Atrial fibrillation
Time Frame: Baseline to 20 years
Baseline to 20 years
Ventricular arrhythmias
Time Frame: Baseline to 20 years
Ventricular ectopic beats, non-sustained and sustained ventricular tachycardia
Baseline to 20 years

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Jessa Hospital
University Hospital, Antwerp
Baker Heart and Diabetes Institute
Victor Chang Cardiac Research Institute

Investigators

  • Study Chair: Guido Claessen, Prof. Dr., UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (ACTUAL)

June 23, 2015

Primary Completion (ANTICIPATED)

June 23, 2035

Study Completion (ANTICIPATED)

June 23, 2040

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (ACTUAL)

December 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 57241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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