A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertrophic Cardiomyopathy
- Sponsor
- Mayo Clinic
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Ventricular arrhythmia incidence in hypertrophic cardiomyopathy
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.
Detailed Description
Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.
Investigators
Jeffrey B. Geske
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Currently or previously enrolled in 17-003514 and 16-009474
- •Adults age \>18 years-old with a diagnosis of hypertrophic cardiomyopathy
- •Both sexes
- •Able to consent
Exclusion Criteria
- •Vulnerable study population
- •Known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation)
- •Pacemaker/ICD implantation
- •Pregnancy
Outcomes
Primary Outcomes
Ventricular arrhythmia incidence in hypertrophic cardiomyopathy
Time Frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Define the incidence ratio of newly diagnosed ventricular arrhythmias in hypertrophic cardiomyopathy, with and without sleep apnea
Atrial fibrillation recurrence in hypertrophic cardiomyopathy
Time Frame: Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring.
Determine the frequency of recurrent atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
Atrial fibrillation incidence in hypertrophic cardiomyopathy
Time Frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Define the incidence ratio of newly diagnosed atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea