Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

Completed

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT03327623
• Lead Sponsor: Mayo Clinic

Brief Summary

The investigators are trying to find out how common sleep apnea is in hypertrophic cardiomyopathy. The purpose of this study is to see if sleep apnea is common in hypertrophic cardiomyopathy and if its presence is associated with changes in the functioning of the body. The investigators want to determine if sleep apnea is associated with electrical disorders of the heart in patients with hypertrophic cardiomyopathy.

Detailed Description

Participants will be healthy volunteers or subjects with the diagnosis of hypertrophic cardiomyopathy (HCM). All patients will a undergo a one time; medical history, physical examination, questionnaires, sleep observation in hospital, blood and urine samples, ultrasound scan of the heart, paced breathing test, ultrasound of brachial artery in the arm, MRI of the heart \& 48 hour ECG Holter monitoring. Comparison between the normal volunteers and subjects with HCM will be made.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Study Start: 2017-11-13
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Obstructive Sleep Apnea (OSA).	Approximately 2 years.	Measured by the Apnea-hypopnea index (AHI). The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, sleep apnea is diagnosed if an AHI ≥5 events/hour.
Determine the severity of Sleep Apnea.	Approximately 2 years.	The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI \< 5 per hour, Mild: AHI ≥ 5, but \< 15 per hour, Moderate: AHI ≥ 15, but \< 30 per hour, Severe: AHI ≥ 30 per hour.
Differences in Autonomic Regulation.	Approximately 2 years.	In persons with hypertrophic cardiomyopathy and sleep apnea vs. those without sleep apnea.
Prevalence of atrial arrhythmias.	Approximately 2 years.	Investigators will determine prevalence of atrial arrhythmias, based on prior ECG documented atrial arrhythmias at any timepoint prior to enrolment and up to 4 weeks after the study date. Participants will also have a 48h ECG (extended Holter) recorder attached to screen for atrial arrhythmias.
Incidence of atrial arrhythmias.	Approximately 5 years.
Frequency of ventricular arrhythmias.	Approximately 5 years.	Investigators will prospectively follow patients with hypertrophic cardiomyopathy to determine the frequency of ventricular arrhythmias in those with vs those without sleep apnea.

Secondary Outcome Measures

Name	Time	Method
Identify novel biomarkers	Approximately 5 years	Participants will be prospectively followed and blood collected to identify biomarkers of arrhythmia, heart failure and prognosis in persons with hypertrophic cardiomyopathy.
Investigate the association of sleep apnea with atrial and ventricular fibrosis	Approximately 7 years	Participants will undergo baseline MRI studies of the heart to determine the burden of fibrosis and its association with sleep apnea. Participants may be invited to complete a follow-up study to track changes in fibrosis.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States