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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geraldo Lorenzi-Filho, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01631006
First received: June 26, 2012
Last updated: December 18, 2014
Last verified: December 2014
  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/Efficacy 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:


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 ]

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631006

Locations
Brazil
Heart Institute
Sao Paulo, Brazil, 05403000
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: December 18, 2014
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:
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 27, 2015