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

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ClinicalTrials.gov Identifier: NCT01631006
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Geraldo Lorenzi-Filho, University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Non-obstructive Hypertrophic Cardiomyopathy Obstructive Hypertrophic Cardiomyopathy Device: CPAP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Acute Hemodynamic Effects of Continous Positive Airway Pressure (CPAP) in Patients With Hypertrophic Cardiomyopathy
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013


Arm Intervention/treatment
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




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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631006


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geraldo Lorenzi-Filho, Associated Professor of Pulmonary Division, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01631006     History of Changes
Other Study ID Numbers: SDC 325209/003
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

Keywords provided by Geraldo Lorenzi-Filho, University of Sao Paulo:
CPAP
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:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases