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OpenTrials
Completed

NCT Number: NCT01631006

Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of disability including heart failure, atrial fibrillation, and sudden death, with an annual mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among patients with established cardiovascular disease, including hypertension and atrial fibrillation and when present may contribute to worse cardiovascular outcome. Although patients with HCM do not necessarily have typical characteristics of patients with OSA, such as obesity and increasing age, there is recent evidence that OSA is extremely common among patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among patients with HCM is independently associated with worse structural and functional impairment of the heart, including atrial and aorta enlargement, worse New York Heart Association functional class, and worse quality of life. Therefore, the recognition and treatment of OSA is a new area of research that may impact in the management of patients with HCM.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Institute

São Paulo, 05403000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • both genders
  • over 18 years-old
  • hemodynamically stable
  • with no other cardiac disease
  • consent form signed

Exclusion criteria

  • presence of pacemaker
  • spontaneous withdrawal
  • previous cardiorespiratory arrest
  • atrial fibrilation during echocardiography

Treatment and study plan

CPAP

Device

A low or high CPAP pressure is delivered for 20 minutes

Primary outcomes

  1. Cadiac performance by echocardiography

    Time frame: acutely

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Acute Hemodynamic Effects of Continous Positive Airway Pressure (CPAP) in Patients With Hypertrophic Cardiomyopathy

Acronym: CPAPandHCM

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 28, 2012
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.