Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

NCT ID: NCT03327623

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-13

Study Completion Date

2024-06-21

Brief Summary

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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

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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.

Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypertrophic Cardiomyopathy (HCM)

Subjects with a diagnosis of Hypertrophic Cardiomyopathy

No interventions assigned to this group

Control

Subjects who are healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Virend Somers, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virend Somers, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1R01HL134885-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-003514

Identifier Type: -

Identifier Source: org_study_id

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