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

Primary Purpose

Arrhythmogenic Right Ventricular Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac exercises and tests
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmogenic Right Ventricular Cardiomyopathy focused on measuring ARVC, Athlete's heart, exercise, CMR, RV contractile reserve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU RennesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

ARVC patients

Endurance athletes with a dilated RV

Endurance athletes with normal RV

Untrained subject with normal RV

Arm Description

Outcomes

Primary Outcome Measures

Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise

Secondary Outcome Measures

Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise
Evolution of S' tricuspid wave during exercise
Evolution of RV fractional area during exercise
Evolution of free wall RV strain during exercise

Full Information

First Posted
August 23, 2021
Last Updated
April 14, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05024708
Brief Title
Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
Acronym
CA2VD
Official Title
Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 16, 2024 (Anticipated)
Study Completion Date
January 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmogenic Right Ventricular Cardiomyopathy
Keywords
ARVC, Athlete's heart, exercise, CMR, RV contractile reserve

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARVC patients
Arm Type
Experimental
Arm Title
Endurance athletes with a dilated RV
Arm Type
Active Comparator
Arm Title
Endurance athletes with normal RV
Arm Type
Active Comparator
Arm Title
Untrained subject with normal RV
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cardiac exercises and tests
Intervention Description
Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)
Primary Outcome Measure Information:
Title
Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
Time Frame
Through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise
Time Frame
Through study completion, an average of 1 month
Title
Evolution of S' tricuspid wave during exercise
Time Frame
Through study completion, an average of 1 month
Title
Evolution of RV fractional area during exercise
Time Frame
Through study completion, an average of 1 month
Title
Evolution of free wall RV strain during exercise
Time Frame
Through study completion, an average of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédéric SCHNELL, MD-PhD
Phone
+33 2.99.28.41.33
Email
Frederic.SCHNELL@chu-rennes.fr
Facility Information:
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric SCHNELL, MD-PhD
Phone
+33 2.99.28.41.33
Email
Frederic.SCHNELL@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Elise BANNIER, PhD
Phone
+33 2 99 28 99 06
Email
elise.bannier@irisa.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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