Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

• ClinicalTrials.gov Identifier: NCT03327623
• Recruitment Status: Recruiting
• First Posted: October 31, 2017
• Last Update Posted: July 25, 2019
• Sponsor: Mayo Clinic
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Virend Somers, Mayo Clinic

Study Description

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

• 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

Groups and Cohorts

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

Outcome Measures

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

• 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)
• Prosthetic valves
• Chronic obstructive pulmonary disease (COPD) (FEV1/Forced vital capacity (FVC) <0.70; FEV1 <80%)
• Known autonomic dysfunction
• Vulnerable study population

Contacts and Locations

Contacts

Contact: CPL Lab; 507-293-2762; CPLHCM@mayo.edu

Locations

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

Sponsors and Collaborators

Mayo Clinic

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Virend Somers, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• 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
• Last Update Posted: July 25, 2019
• Last Verified: July 2019

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; 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; Heart Valve Diseases