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

NCT01631006 | Completed DMC

• 1 other identifier: SDC 325209/003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-obstructive Hypertrophic Cardiomyopathy; Obstructive Hypertrophic Cardiomyopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cadiac performance by echocardiography

  acutely

Study Arms (2)

Low CPAP pressure

SHAM COMPARATOR

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

Device: CPAP

High CPAP pressure

ACTIVE COMPARATOR

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

Device: CPAP

Interventions

CPAP DEVICE

A low or high CPAP pressure is delivered for 20 minutes

High CPAP pressure; Low CPAP pressure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both genders
• over 18 years-old
• hemodynamically stable
• with no other cardiac disease
• consent form signed

You may not qualify if:

• presence of pacemaker
• spontaneous withdrawal
• previous cardiorespiratory arrest
• atrial fibrilation during echocardiography

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Heart Institute

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (1)

• Nerbass FB, Salemi VMC, Pedrosa RP, Portilho NP, Ferreira-Filho JCA, Moriya HT, Antunes MO, Arteaga-Fernandez E, Drager LF, Lorenzi-Filho G. Acute Effects of Nasal CPAP in Patients With Hypertrophic Cardiomyopathy. Chest. 2016 Nov;150(5):1050-1058. doi: 10.1016/j.chest.2016.05.004. Epub 2016 May 7.

  PMID: 27167210 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor of Pulmonary Division

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

BR (1)