Clinical trial NCT03327623: Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)
Official title: A Prevalence and Incidence Study Investigating the Burden of Atrial and Ventricular Arrhythmias in Patients With Hypertrophic Cardiomyopathy and Sleep Apnea.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Keywords: sleep apnea
arrhythmia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-10-31
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and Subjects from The Mayo Clinic Hypertrophic Cardiomyopathy (HCM) Registry who reside in Minnesota.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Obstructive Sleep Apnea (OSA).
timeFrame: Approximately 2 years.
measure: Determine the severity of Sleep Apnea.
timeFrame: Approximately 2 years.
measure: Differences in Autonomic Regulation.
timeFrame: Approximately 2 years.
measure: Prevalence of atrial arrhythmias.
timeFrame: Approximately 2 years.
measure: Incidence of atrial arrhythmias.
timeFrame: Approximately 5 years.
measure: Frequency of ventricular arrhythmias.
timeFrame: Approximately 5 years.
Secondary outcomes:
measure: Identify novel biomarkers
timeFrame: Approximately 5 years
measure: Investigate the association of sleep apnea with atrial and ventricular fibrosis
timeFrame: Approximately 7 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD
role: PRINCIPAL_INVESTIGATOR
References: