NCT05024708

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

August 23, 2021

Last Update Submit

April 14, 2023

Conditions

Arrhythmogenic Right Ventricular Cardiomyopathy

Keywords

ARVC, Athlete's heart, exercise, CMR, RV contractile reserve

Outcome Measures

Primary Outcomes (1)

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

    Through study completion, an average of 1 month

Secondary Outcomes (4)

  • Evolution of Tricuspid annular plane systolic excursion (TAPSE) during exercise

    Through study completion, an average of 1 month

  • Evolution of S' tricuspid wave during exercise

    Through study completion, an average of 1 month

  • Evolution of RV fractional area during exercise

    Through study completion, an average of 1 month

  • Evolution of free wall RV strain during exercise

    Through study completion, an average of 1 month

Study Arms (4)

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

Interventions

Cardiac exercises and testsOTHER

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

ARVC patientsEndurance athletes with a dilated RVEndurance athletes with normal RVUntrained subject with normal RV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

Arrhythmogenic Right Ventricular DysplasiaMotor Activity

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesCardiomyopathiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Central Study Contacts

Frédéric SCHNELL, MD-PhD

CONTACT

+33 2.99.28.41.33Frederic.SCHNELL@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 27, 2021

Study Start

January 16, 2023

Primary Completion

January 16, 2024

Study Completion

January 16, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)