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Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)

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Mayo Clinic

Status

Completed

Conditions

Hypertrophic Cardiomyopathy

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03327623
1R01HL134885-01 (U.S. NIH Grant/Contract)
17-003514

Details and patient eligibility

About

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.

Full 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.

Enrollment

290 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

290 participants in 2 patient groups

Hypertrophic Cardiomyopathy (HCM)
Description:
Subjects with a diagnosis of Hypertrophic Cardiomyopathy
Control
Description:
Subjects who are healthy volunteers

Trial contacts and locations

1

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Central trial contact

CPL Lab

Data sourced from clinicaltrials.gov

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