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

Obstructive Hypertrophic Cardiomyopathy Clinical Trial

— CPAPandHCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631006
• Other study ID #: SDC 325209/003
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: December 18, 2014
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Non-obstructive Hypertrophic Cardiomyopathy
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Device:
• CPAP
A low or high CPAP pressure is delivered for 20 minutes

Locations

Country	Name	City	State
Brazil	Heart Institute	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cadiac performance by echocardiography		acutely	Yes