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

This study is currently recruiting participants.
Verified January 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Geraldo Lorenzi-Filho, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01631006
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Cadiac performance by echocardiography [ Time Frame: acutely ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631006

Locations
Brazil
Heart Institute Recruiting
Sao Paulo, Brazil, 05403000
Contact: Geraldo Lorenzi-Filho, MD, PhD     +551126615000 ext 5486     geraldo.lorenzi@gmail.com    
Contact: Flávia B Nerbass, PT     +551126615000 ext 5486     fbnerbass@gmail.com    
Principal Investigator: Geraldo Lorenzi-Filho, MD, PhD            
Sub-Investigator: Flávia B Nerbass, PT            
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

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
Study First Received: June 26, 2012
Last Updated: June 27, 2012
Health Authority: Brazil: Institutional Review Board

Keywords provided by 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:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
 Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 17, 2013