Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

A Prevalence and Incidence Study Investigating the Burden of Atrial and Ventricular Arrhythmias in Patients With Hypertrophic Cardiomyopathy and Sleep Apnea.

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.

Study Overview

• Status: Recruiting
• Conditions: 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
• Enrollment (Estimated): 520

Contacts and Locations

• Study Contact: Name: CPL Lab; Phone Number: 507-293-2762; Email: CPLHCM@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Sub-Investigator: Grace Lin, MD
      • Sub-Investigator: Anwar A Chahal, MBChB MRCP
      • Contact: CPL Lab; Phone Number: 507-293-2762; Email: CPLHCM@mayo.edu
      • Principal Investigator: Virend K Somers, MD, PhD
      • 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: Sean M Caples, DO MSc
      • Sub-Investigator: Erik K St Louis, MD
      • Sub-Investigator: Thomas Olson, PhD
      • Sub-Investigator: Wolfgand Singer, MD
      • Sub-Investigator: Shreyas Venkataraman, MBBS
      • Sub-Investigator: Shahid Karim, MBBS MRCP
      • Sub-Investigator: Peter A Brady, MD FRCP FHRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

Inclusion criteria:

• Adults with a diagnosis of HCM
• Able to consent
• Non-pregnant
• Healthy Controls free of hypertrophic cardiomyopathy and without a definitive family history of hypertrophic cardiomyopathy.

Exclusion criteria:

• Decompensated Heart failure at time of enrollment (prior history of HF is not an exclusion criteria)
• Severe (known) Chronic obstructive pulmonary disease (COPD) (FEV1 between 30 and 50 percent of normal)
• Vulnerable study populations except for minorities (minorities may be targeted to achieve 25% minority recruitment required by the NIH)
• Pregnant women
• Children

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Virend Somers, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: sleep apnea; arrhythmia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Sleep Apnea Syndromes; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 17-003514; 1R01HL134885-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No