Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR) (CA2VD)

April 14, 2023 updated by: Rennes University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARVC patients
Other: Cardiac exercises and tests
Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)
Active Comparator: Endurance athletes with a dilated RV
Other: Cardiac exercises and tests
Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)
Active Comparator: Endurance athletes with normal RV
Other: Cardiac exercises and tests
Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)
Experimental: Untrained subject with normal RV
Other: Cardiac exercises and tests
Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month
Evolution of S' tricuspid wave during exercise
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month
Evolution of RV fractional area during exercise
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month
Evolution of free wall RV strain during exercise
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month

Collaborators and Investigators

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

Sponsor

Rennes University Hospital

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)

January 16, 2023

Primary Completion (Anticipated)

January 16, 2024

Study Completion (Anticipated)

January 16, 2024

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC21_9886_CA2VD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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