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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic

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.

Condition or disease
Hypertrophic Cardiomyopathy

Detailed Description:
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.

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 2021
Estimated Study Completion Date : June 2025


Group/Cohort
Hypertrophic Cardiomyopathy (HCM)
Subjects with a diagnosis of Hypertrophic Cardiomyopathy
Control
Subjects who are healthy volunteers



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood plasma, serum and urine.


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

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)
  • Prior alcohol septal ablation
  • Surgical myectomy
  • Prosthetic valves
  • Current smokers or recently quit (<6 months)
  • Chronic obstructive pulmonary disease (COPD) (FEV1/Forced vital capacity (FVC) <0.70; FEV1 <80%)
  • Known autonomic dysfunction
  • (Fully) Treated sleep apnea (mandibular device, CPAP)
  • Vulnerable study population
  • Prior catheter ablation for atrial fibrillation

Information from the National Library of Medicine

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


Contacts
Contact: Lisa D. Block 507 255 0492 cpl@mayo.edu
Contact: Anwar A Chahal, MB ChB MRCP 507 255 1272

Locations
United States, Minnesota
Mayo Clinic Recruiting
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         
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Virend Somers, MD Mayo Clinic

Responsible Party: Virend Somers, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03327623     History of Changes
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: March 6, 2018
Last Verified: March 2018
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

Keywords provided by Virend Somers, Mayo Clinic:
sleep apnea
arrhythmia

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
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
Heart Valve Diseases