Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)

NCT ID: NCT05024708

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2024-01-16

Brief Summary

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Prospective, nonrandomized, single-center, comparative study to define if right ventricular (RV) contractile reserve assessed by exercise CMR helps to improve the differential diagnosis between pathological and physiological remodeling of the RV; ie. arrhythmogenic right ventricular cardiomyopathy (ARVC) and athlete's heart.

Detailed Description

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Comparison of the RV contractile reserve in 4 groups of patients: Arrhythmogenic right ventricular cardiomyopathy (ARVC) patients; endurance athletes with a dilated RV, endurance athletes with normal RV, untrained subject with normal RV.

Patients will come to the hospital for 3 visits (3 half days):

* Visit 1: clinical evaluation, rest ECG, rest echocardiography, cardio-pulmonary exercise test.
* Visit 2: exercise echocardiography, holter ECG monitor (48 yours)
* Visit 3: rest CMR and exercise CMR (ergocycle)

Conditions

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Arrhythmogenic Right Ventricular Cardiomyopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ARVC patients

Group Type EXPERIMENTAL

Cardiac exercises and tests

Intervention Type OTHER

Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)

Endurance athletes with a dilated RV

Group Type ACTIVE_COMPARATOR

Cardiac exercises and tests

Intervention Type OTHER

Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)

Endurance athletes with normal RV

Group Type ACTIVE_COMPARATOR

Cardiac exercises and tests

Intervention Type OTHER

Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)

Untrained subject with normal RV

Group Type EXPERIMENTAL

Cardiac exercises and tests

Intervention Type OTHER

Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)

Interventions

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Cardiac exercises and tests

Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men or women aged 18 years and older,

* patients with confirmed ARVC, but with no major RV dysfunction (RVEF \>40%)
* endurance athletes with dilated RV
* endurance athletes with non-dilated RV
* untrained healthy subjects with non-dilated RV
* who signed a written free and informed consent:

Exclusion Criteria

* Patients with other cardiovascular disease;
* Contra-indication to CMR (in particular presence of a non-CMR compatible implantable cardiac defibrillator);
* Patients with permanent supraventricular arrhythmia;
* Patients unable to perform an exercise test on an ergocycle;
* Person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frédéric SCHNELL, MD-PhD

Role: CONTACT

+33 2.99.28.41.33

Facility Contacts

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Frédéric SCHNELL, MD-PhD

Role: primary

+33 2.99.28.41.33

Elise BANNIER, PhD

Role: backup

+33 2 99 28 99 06

Other Identifiers

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35RC21_9886_CA2VD

Identifier Type: -

Identifier Source: org_study_id

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