Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03327623
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: CPL Lab 507-293-2762 CPLHCM@mayo.edu

Locations
Layout table for location information
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         
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Virend Somers, MD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Layout table for additonal information
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 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for 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