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 : March 6, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||662 participants|
|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 2021|
|Estimated Study Completion Date :||June 2025|
Hypertrophic Cardiomyopathy (HCM)
Subjects with a diagnosis of Hypertrophic Cardiomyopathy
Subjects who are healthy volunteers
- 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
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: Lisa D. Block||507 255 firstname.lastname@example.org|
|Contact: Anwar A Chahal, MB ChB MRCP||507 255 1272|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Lisa D Block 507-255-8794 CPL@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|
|Principal Investigator:||Virend Somers, MD||Mayo Clinic|