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

NCT ID: NCT01631006

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non-obstructive Hypertrophic Cardiomyopathy Obstructive Hypertrophic Cardiomyopathy

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Low CPAP pressure

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

Group Type SHAM_COMPARATOR

CPAP

Intervention Type DEVICE

A low or high CPAP pressure is delivered for 20 minutes

High CPAP pressure

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

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

A low or high CPAP pressure is delivered for 20 minutes

Interventions

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CPAP

A low or high CPAP pressure is delivered for 20 minutes

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Geraldo Lorenzi-Filho

Associated Professor of Pulmonary Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heart Institute

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 27167210 (View on PubMed)

Other Identifiers

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SDC 325209/003

Identifier Type: -

Identifier Source: org_study_id