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

University of Sao Paulo

Status: Completed

Conditions: Non-obstructive Hypertrophic Cardiomyopathy; Obstructive Hypertrophic Cardiomyopathy

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01631006

SDC 325209/003

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Low CPAP pressure

Sham Comparator group

Description:

Patients are submmited to a CPAP with low pressure for 20 minutes

Treatment:

Device: CPAP

High CPAP pressure

Active Comparator group

Description:

Patients are submmited to a high pressure of CPAP for 20 minutes

Treatment:

Device: CPAP