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Completed

NCT Number: NCT03327623

Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Decompensated Heart failure at time of enrollment (prior history of HF is not an exclusion criteria)
  • 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

Treatment and study plan

Primary outcomes

  1. Prevalence of Obstructive Sleep Apnea (OSA).

    Time frame: 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.

  2. Determine the severity of Sleep Apnea.

    Time frame: 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.

  3. Differences in Autonomic Regulation.

    Time frame: Approximately 2 years.

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

  4. Prevalence of atrial arrhythmias.

    Time frame: 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.

  5. Incidence of atrial arrhythmias.

    Time frame: Approximately 5 years.

  6. Frequency of ventricular arrhythmias.

    Time frame: 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 outcomes

  1. Identify novel biomarkers

    Time frame: 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.

  2. Investigate the association of sleep apnea with atrial and ventricular fibrosis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Prevalence and Incidence Study Investigating the Burden of Atrial and Ventricular Arrhythmias in Patients With Hypertrophic Cardiomyopathy and Sleep Apnea.

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2017
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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