An observational study in Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy, sponsored by Rennes University Hospital. Recruiting at 6 sites in 6 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by Rennes University Hospital · Observational
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.
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.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's planned enrollment of 200 is above the median of 157 across 386 observational studies indexed under Fibrosis.
Browse Fibrosis studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
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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.
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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:
non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR
Occurrence of a major cardiac event
During a follow-up of 5 years, occurrence of a major cardiac event defined by either: death, death of cardiovascular cause; hospitalization for cardiac event; any major arrhythmic event defined by arrhythmic cardiac arrest, sustained ventricular tachycard
Time frame: five years after inclusion
Morphological end-point
Alteration of left ventricular (LV) function defined by a decrease in LVEF as compared to the initial evaluation (≥10%, or occurrence of a new wall motion abnormality assessed the same imaging technic, i.e. echocardiography or CMR)
Time frame: five years after inclusion
Functional end-point
alteration of exercise capacity, defined by a reduction ≥10% of peak VO2, not explained by training changes
Time frame: five years after inclusion
Arrhythmic end-point
Occurrence of a non-sustained VT (NSVT), defined as a tachycardia originating in the ventricle \>100 beats/min and lasting ≥3 beats but less than 30 seconds.
Time frame: five years after inclusion
Started Oct 2018 (actual). Primary completion is estimated for Oct 2020, 24 months after the start.
Of 177 non-industry observational studies under Fibrosis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 105. This study's planned 24 months is below that.
Counting every sponsor, half of 186 studies reached it within 48 months; a quarter within 21 and three quarters within 105.
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