A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04112290

Enrollment

260

Registered

2019-10-02

Start date

2019-11-05

Completion date

2027-12-01

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

Keywords

Atrial fibrillation, Ventricular tachycardia, Arrhythmia, Hypertrophic cardiomyopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJeffrey Geske, MD

Mayo Clinic

Outcome results