Clinical trial NCT03780231: Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
Official title: Effect of Intense Sport Practice in Athletes With Non-ischemic Scar
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy
Keywords: Athletes
Late gadolinium enhancement
fibrosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any athlete, aged of more than 15 years, symptomatic or not, in whom non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR.

Brief summary: The prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines to not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice.

The principal objective of the study is to evaluate during a five-years follow up, the clinical outcome of athletes with this kind of findings. The secondary objective is the determination of prognostic factors. The management and follow-up of the athletes will be let at the appraisal of each center.

Detailed description: The presence of a scar, assessed by late gadolinium enhancement (LGE) on cardiac resonance imaging (CMR), is associated with a poor prognosis in patients with ischemic heart disease or cardiomyopathy. But the prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines do not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice.

The objective of the study is to evaluate the clinical outcome of athletes with isolated non-ischemic LGE with no underlying "labelled" cardiomyopathy during a five-years follow-up. The secondary objective is the determination of prognostic factors based on the baseline inclusion data: indication of CMR (i.e. symptoms, abnormal ECG, presence and morphology of arrhythmias, abnormal echocardiography); localization and amount of LGE, left and right ventricular geometry and function, characteristics of sport practice (amount, type, competition).

The management of the athletes will be let at the appraisal of each centre, as regards to the initial assessment, the follow-up and the medical clearance for competitive sports participation. Nevertheless, due to the absence of consensus, we propose that the patient should at least undergo clinical examination, ECG, echocardiography, cardiopulmonary exercise test (CPET) and holter ECG each year. A CMR should be performed at one and five years.

Eligibility criteria: Inclusion Criteria:

* Any athlete, aged of more than 15 years, symptomatic or not,
* in whom non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR. Scare of an acute myocarditis will also be included.

Athletes will be defined by a practice of ≥4 hours/week of sport activity and/or competitive sport activity at the time of the assessment which triggered the realization of the 1st CMR.

Exclusion Criteria:

* Athletes with any unequivocal cardiac disease that might explain the LGE (i.e. hypertrophic cardiomyopathy, ischemic cardiac disease). In case of borderline or doubtful diagnosis the athlete can still be included (for example an athlete with a dilated LV and borderline function, or with borderline wall thickness).
* Patients who refuse their participation in the study.
* Patients under legal protection or deprived of their liberty.

Primary outcomes:
measure: Occurrence of a major cardiac event
timeFrame: five years after inclusion
Secondary outcomes:
measure: Morphological end-point
timeFrame: five years after inclusion
measure: Functional end-point
timeFrame: five years after inclusion
measure: Arrhythmic end-point
timeFrame: five years after inclusion
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker IDI Heart and Diabetes Institute
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Rennes
country: France
facility: CHU de Rennes
city: Sarrebruck
country: Germany
facility: Saarland University
city: Luxembourg
country: Luxembourg
facility: Hospital Center of Luxembourg
city: London
country: United Kingdom
facility: St. George's University of London
Study officials:
affiliation: Rennes University Hospital
name: Frederic FC SCHNELL, MD
role: STUDY_DIRECTOR
References: