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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL134885-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertrophic Cardiomyopathy (HCM) | Subjects with a diagnosis of Hypertrophic Cardiomyopathy | ||
| Control | Subjects who are healthy volunteers |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify novel biomarkers | Participants will be prospectively followed and blood collected to identify biomarkers of arrhythmia, heart failure and prognosis in persons with hypertrophic cardiomyopathy. | Approximately 5 years |
| Investigate the association of sleep apnea with atrial and ventricular fibrosis |
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Inclusion criteria:
Exclusion criteria:
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Healthy volunteers and Subjects from The Mayo Clinic Hypertrophic Cardiomyopathy (HCM) Registry who reside in Minnesota.
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| Name | Affiliation | Role |
|---|---|---|
| Virend Somers, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D012891 | Sleep Apnea Syndromes |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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Blood plasma, serum and urine.
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. |
| Approximately 7 years |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |