Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03327623

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

662

Enrollment

Location

150.6

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

Anticipated 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 :

Nov 13, 2017

Anticipated Primary Completion Date :

Jun 1, 2027

Anticipated Study Completion Date :

Jun 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Hypertrophic Cardiomyopathy (HCM) Subjects with a diagnosis of Hypertrophic Cardiomyopathy
Control Subjects who are healthy volunteers

Outcome Measures

Primary Outcome Measures

Prevalence of Obstructive Sleep Apnea (OSA). [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. [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. [Approximately 2 years.]
In persons with hypertrophic cardiomyopathy and sleep apnea vs. those without sleep apnea.
Prevalence of atrial arrhythmias. [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. [Approximately 5 years.]
Frequency of ventricular arrhythmias. [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

Identify novel biomarkers [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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