Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327623
• Other study ID #: 17-003514
• Secondary ID: 1R01HL134885-01
• Status: Recruiting
• Start date: November 13, 2017
• Est. completion date: June 2030

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: CPL Lab
• Phone: 507-293-2762
• Email: CPLHCM[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: June 2030
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Differences in Autonomic Regulation.	In persons with hypertrophic cardiomyopathy and sleep apnea vs. those without sleep apnea.	Approximately 2 years.
Primary	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.
Primary	Incidence of atrial arrhythmias.		Approximately 5 years.
Primary	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	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
Secondary	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