Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)
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ClinicalTrials.gov Identifier: NCT03327623 |
Recruitment Status :
Recruiting
First Posted : October 31, 2017
Last Update Posted : July 6, 2022
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Condition or disease |
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Hypertrophic Cardiomyopathy |
Study Type : | Observational |
Estimated Enrollment : | 662 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prevalence and Incidence Study Investigating the Burden of Atrial and Ventricular Arrhythmias in Patients With Hypertrophic Cardiomyopathy and Sleep Apnea. |
Actual Study Start Date : | November 13, 2017 |
Estimated Primary Completion Date : | June 2027 |
Estimated Study Completion Date : | June 2030 |

Group/Cohort |
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Hypertrophic Cardiomyopathy (HCM)
Subjects with a diagnosis of Hypertrophic Cardiomyopathy
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Control
Subjects who are healthy volunteers
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- 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.
- 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.
- Differences in Autonomic Regulation. [ Time Frame: Approximately 2 years. ]In persons with hypertrophic cardiomyopathy and sleep apnea vs. those without sleep apnea.
- 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.
- Incidence of atrial arrhythmias. [ Time Frame: Approximately 5 years. ]
- 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.
- 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.
- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion criteria:
- Able to consent
- Non-pregnant
Exclusion criteria:
- Decompensated Heart failure (symptoms and N-terminal pro b-type natriuretic peptide (NT-proBNP) >332 ng/L in the absence of renal failure or competing cause)
- Prosthetic valves
- Chronic obstructive pulmonary disease (COPD) (FEV1/Forced vital capacity (FVC) <0.70; FEV1 <80%)
- Known autonomic dysfunction
- Vulnerable study population

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327623
Contact: CPL Lab | 507-293-2762 | CPLHCM@mayo.edu |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: CPL Lab 507-293-2762 CPLHCM@mayo.edu | |
Principal Investigator: Virend K Somers, MD, PhD | |
Sub-Investigator: Anwar A Chahal, MBChB MRCP | |
Principal Investigator: Meghna P Mansukhani, MD | |
Sub-Investigator: Bernard J Gersh, MBChB DPhil | |
Sub-Investigator: Jeffrey B Geske, MD | |
Sub-Investigator: Steve R Ommen, MD | |
Sub-Investigator: Peter A Brady, MD FRCP FHRS | |
Sub-Investigator: Sean M Caples, DO MSc | |
Sub-Investigator: Erik K St Louis, MD | |
Sub-Investigator: Grace Lin, MD | |
Sub-Investigator: Thomas Olson, PhD | |
Sub-Investigator: Wolfgand Singer, MD | |
Sub-Investigator: Shreyas Venkataraman, MBBS | |
Sub-Investigator: Shahid Karim, MBBS MRCP |
Principal Investigator: | Virend Somers, MD | Mayo Clinic |
Responsible Party: | Virend Somers, MD, PhD, Principal Investigator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT03327623 |
Other Study ID Numbers: |
17-003514 16-009474 1R01HL134885-01 ( U.S. NIH Grant/Contract ) FP00093543 ( Other Grant/Funding Number: Paul and Ruby Tsai and Family Award ) |
First Posted: | October 31, 2017 Key Record Dates |
Last Update Posted: | July 6, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
sleep apnea arrhythmia |
Sleep Apnea Syndromes Cardiomyopathies Cardiomyopathy, Hypertrophic Hypertrophy Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Heart Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Aortic Stenosis, Subvalvular Aortic Valve Stenosis Aortic Valve Disease Heart Valve Diseases |