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

This study has been completed.
Information provided by (Responsible Party):
Geraldo Lorenzi-Filho, University of Sao Paulo Identifier:
First received: June 26, 2012
Last updated: December 18, 2014
Last verified: December 2014
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.

Condition Intervention
Non-obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Acute Hemodynamic Effects of Continous Positive Airway Pressure (CPAP) in Patients With Hypertrophic Cardiomyopathy

Resource links provided by NLM:

Further study details as provided by Geraldo Lorenzi-Filho, University of Sao Paulo:

Primary Outcome Measures:
  • Cadiac performance by echocardiography [ Time Frame: acutely ]

Enrollment: 26
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Low CPAP pressure
Patients are submmited to a CPAP with low pressure for 20 minutes
Device: CPAP
A low or high CPAP pressure is delivered for 20 minutes
Active Comparator: High CPAP pressure
Patients are submmited to a high pressure of CPAP for 20 minutes
Device: CPAP
A low or high CPAP pressure is delivered for 20 minutes


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01631006

Heart Institute
Sao Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Geraldo Lorenzi-Filho, Associated Professor of Pulmonary Division, University of Sao Paulo Identifier: NCT01631006     History of Changes
Other Study ID Numbers: SDC 325209/003
Study First Received: June 26, 2012
Last Updated: December 18, 2014

Keywords provided by Geraldo Lorenzi-Filho, University of Sao Paulo:
Hypertrophic cardiomyopathy
Blood Pressure
The focus of the present study is to evaluate the acute hemodynamic effects of CPAP in patients with non-obstructive and obstructive hypertrophic cardiomyopathy

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical processed this record on May 25, 2017