Prolonged Monitoring to Detect Ventricular Arrhythmias in Presymptomatic Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) Patients (PREPARE)
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Purpose
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition characterized by life threatening heart racing, presenting with palpitations, cardiac arrest (collapse requiring an ambulance) or sudden death. The disease affects the right ventricle, the part of the heart that pumps blood to the lungs. ARVC is diagnosed with a wide range of tests that focus on the pumping function and the electrical signals from the right ventricle. These factors are summarized in a score that forms the ARVC Task Force Criteria. Genetic testing has identified 5 different genes that lead to ARVC, which are detected in about 60% of patients with ARVC. This allows doctors to test family members of the patient with ARVC to determine if they are at risk of developing the condition. Currently, family members undergo testing that includes imaging and electrical tests such as a 24-hour monitor to determine if they have evidence of ARVC. With increasing frequency, family members are found to have the gene that may lead to ARVC, but little or no evidence that their hearts are affected. This may be because the family member is too young to develop the condition, or that other factors that we do not understand have protected them from developing it.
The PREPARE study will study 100 patients that carry a gene that can lead to ARVC, but do not have anything more than minor evidence that the condition is present. These patients will not have heart racing on their initial 24-hour monitor. These patients will undergo long term monitoring with an implanted heart monitor that is inserted with a minor surgical procedure, which will detect abnormal heart rhythms that may provide a clue that heart racing from ARVC is present that is not detected with a 24-hour monitor that is performed on an annual basis (St. Jude Confirm implantable loop recorder). These patients will be enrolled in 10 adult and pediatric centers across Canada, and followed for 3 years after their heart monitor is implanted. If heart racing is detected, patients will discuss these results with their doctor to discuss what it means to them.
| Condition |
|---|
|
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prolonged Monitoring to Detect Ventricular Arrhythmias in Presymptomatic ARVC Patients |
- Detection of ≥8 beats of wide QRS complex tachycardia considered ventricular tachycardia (HR>120 bpm*) by the ILR [ Time Frame: 3 year monitoring follow-up ] [ Designated as safety issue: No ]* an algorithm to determine the ventricular tachycardia detection rate
- Comparison of ventricular arrhythmia burden between routine [ Time Frame: 3 year monitoring follow-up ] [ Designated as safety issue: No ]* an algorithm to determine the ventricular tachycardia detection rate
- Change in 2010 Task Force Criteria Score from enrollment to 3-year follow-up. [ Time Frame: 3 year monitoring follow-up ] [ Designated as safety issue: No ]
- Detection of ≥30 seconds of wide QRS complex tachycardia considered ventricular tachycardia (HR>120 bpm*). [ Time Frame: 3 year monitoring follow-up ] [ Designated as safety issue: No ]
- Proportion of patients that go on to receive an ICD [ Time Frame: 3 year monitoring follow-up ] [ Designated as safety issue: No ]
- Proportion of patients that develop symptomatic sustained ventricular tachycardia [ Time Frame: 3 year monitoring follow-up ] [ Designated as safety issue: No ]
- Proportion of patients that develop sustained ventricular tachycardia, cardiac arrest or sudden death [ Time Frame: 3 year monitoring follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Presymptomatic ARVC gene carriers
ARVC gene positive patients without manifest ARVC after standard screening clinical testing.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
ARVC gene carriers with minimal or no evidence of being clinically affected
Inclusion Criteria:
- Identification of a pathogenic mutation† categorized as associated or probably associated with ARVC
- Failure to meet definite revised Task Force Criteria for ARVC. Mutation carriers by definition have a major criterion, so included patients may have 1 minor criteria, but would meet Task Force Criteria for ARVC with 2 minor criteria or 1 major criterion.
- < 200 PVCs / hour on screening Holter monitor
- Age > 2 years
Exclusion Criteria:
- Implantable device in place (pacemaker, ICD)
- Age < 2 years
- Mutation represents a variant of unknown significance with reasonable probability that it may not be disease causing
- Non-sustained ventricular tachycardia on screening Holter monitor (≥8 beats > 100 bpm) and/or ≥ 200 PVCs / hour
- Previous syncope or palpitations attributed to ARVC by the site investigator
- Meets definite revised Task Force Criteria for ARVC (≥2 minor criteria and/or ≥1 additional major criterion). These ARVC patients who do not have an implanted device (ICD or pacemaker) will be included in a parallel voluntary registry separate from the study.
Contacts and Locations| Contact: Andrew D Krahn, MD | 5196633746 | akrahn@uwo.ca |
| Contact: Denise Hulley, RCT | 5196858500 ext 34852 | denise.hulley@lhsc.on.ca |
| Canada, Ontario | |
| University of Western Ontario | Recruiting |
| London, Ontario, Canada, N6A 5A5 | |
| Principal Investigator: Andrew D Krahn, MD | |
| Principal Investigator: | Andrew Krahn, MD FRCPC | University of Western Ontario, Canada |
More Information
Additional Information:
No publications provided
| Responsible Party: | Andrew Krahn, principal investigator, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01271816 History of Changes |
| Other Study ID Numbers: | R-10-532, 17390 |
| Study First Received: | January 4, 2011 |
| Last Updated: | February 10, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
|
genetics sudden death monitoring loop recorder cardiomyopathy |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Arrhythmogenic Right Ventricular Dysplasia Cardiomyopathies Heart Diseases Cardiovascular Diseases |
Pathologic Processes Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 16, 2013