Arrhythmogenic Right Ventricular CardiomyopathyCA2VDNCT05024708
Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
A study testing Cardiac exercises and tests in people with Arrhythmogenic Right Ventricular Cardiomyopathy, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmogenic Right Ventricular Cardiomyopathy
- What is being tested?
- Cardiac exercises and tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2023to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Being tested
- Cardiac exercises and tests
- Keywords
- ARVC, Athlete's heart, exercise, CMR, RV contractile reserve
- Medical subject headings
- Arrhythmogenic Right Ventricular Dysplasia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac exercises and testsOther
Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)
| Study group | Role | What they receive |
|---|---|---|
| ARVC patients | Experimental | Not described Receives: Other: Cardiac exercises and tests |
| Endurance athletes with a dilated RV | Active comparator | Not described Receives: Other: Cardiac exercises and tests |
| Endurance athletes with normal RV | Active comparator | Not described Receives: Other: Cardiac exercises and tests |
| Untrained subject with normal RV | Experimental | Not described Receives: Other: Cardiac exercises and tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
Measured: Through study completion, an average of 1 month
Secondary outcomes (4)
Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise
Measured: Through study completion, an average of 1 month
Evolution of S' tricuspid wave during exercise
Measured: Through study completion, an average of 1 month
Evolution of RV fractional area during exercise
Measured: Through study completion, an average of 1 month
Evolution of free wall RV strain during exercise
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start16 Jan 2023
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Why it stopped: Inclusions were in February 2024, following the replacement of the MRI scanner in which the stress-induction system had been installed. To date, technical tests were conducted but failed to establish a reliable system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmogenic Right Ventricular CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024708
- Sponsor's protocol ID
- 35RC21_9886_CA2VD
- Acronym
- CA2VD
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
- ClinicalTrials.gov ID
- NCT05024708
- Acronym / sponsor ID
- CA2VD / 35RC21_9886_CA2VD
- Keywords
- ARVC, Athlete's heart, exercise, CMR, RV contractile reserve
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusions were in February 2024, following the replacement of the MRI scanner in which the stress-induction system had been installed. To date, technical tests were conducted but failed to establish a reliable system.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARVC patients | Experimental | Other: Cardiac exercises and tests |
| Endurance athletes with a dilated RV | Active comparator | Other: Cardiac exercises and tests |
| Endurance athletes with normal RV | Active comparator | Other: Cardiac exercises and tests |
| Untrained subject with normal RV | Experimental | Other: Cardiac exercises and tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women aged 18 years and older,
- who signed a written free and informed consent:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac exercises and testsRest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle) | Other | ARVC patients, Endurance athletes with a dilated RV, Endurance athletes with normal RV, Untrained subject with normal RV |
Primary outcome
Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise
Time frame: Through study completion, an average of 1 month
4 secondary outcomes
Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise
Time frame: 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
Evolution of RV fractional area during exercise
Time frame: 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
Results and safety
The study was stopped early (reason given: Inclusions were in February 2024, following the replacement of the MRI scanner in which the stress-induction system had been installed. To date, technical tests were conducted but failed to establish a reliable system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac exercises and tests in people with Arrhythmogenic Right Ventricular Cardiomyopathy, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusions were in February 2024, following the replacement of the MRI scanner in which the stress-induction system had been installed. To date, technical tests were conducted but failed to establish a reliable system.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of right ventricular ejection fraction (RVEF) assessed with CMR during exercise (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.