Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

NCT03327623 | Completed

• 2 other identifiers: 17-0035141R01HL134885-01
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

sleep apnea; arrhythmia

Outcome Measures

Primary Outcomes (6)

• Prevalence of Obstructive Sleep Apnea (OSA).

  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.

  Approximately 2 years.

• Determine the severity of Sleep Apnea.

  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.

  Approximately 2 years.

• Differences in Autonomic Regulation.

  In persons with hypertrophic cardiomyopathy and sleep apnea vs. those without sleep apnea.

  Approximately 2 years.

• Prevalence of atrial arrhythmias.

  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.

  Approximately 2 years.

• Incidence of atrial arrhythmias.

  Approximately 5 years.

• Frequency of ventricular arrhythmias.

  Investigators will prospectively follow patients with hypertrophic cardiomyopathy to determine the frequency of ventricular arrhythmias in those with vs those without sleep apnea.

  Approximately 5 years.

Secondary Outcomes (2)

• Identify novel biomarkers

  Approximately 5 years

• Investigate the association of sleep apnea with atrial and ventricular fibrosis

  Approximately 7 years

Study Arms (2)

Hypertrophic Cardiomyopathy (HCM)

Subjects with a diagnosis of Hypertrophic Cardiomyopathy

Control

Subjects who are healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and Subjects from The Mayo Clinic Hypertrophic Cardiomyopathy (HCM) Registry who reside in Minnesota.

You may qualify if:

• Adults with a diagnosis of HCM
• Able to consent
• Non-pregnant
• Healthy Controls free of hypertrophic cardiomyopathy and without a definitive family history of hypertrophic cardiomyopathy.

You may not qualify if:

• Severe (known) Chronic obstructive pulmonary disease (COPD) (FEV1 between 30 and 50 percent of normal)
• Vulnerable study populations except for minorities (minorities may be targeted to achieve 25% minority recruitment required by the NIH)
• Pregnant women
• Children

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma, serum and urine.

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Sleep Apnea Syndromes; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Virend Somers, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 31, 2017
• Study Start: November 13, 2017
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)