A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

Active, not recruiting

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT04112290
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-09-28
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Study Start: 2019-11-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventricular arrhythmia incidence in hypertrophic cardiomyopathy	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	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	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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States