Effectiveness of the Treatment With Continuous Positive Airway Pressure(CPAP)in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing

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

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-04-30

Brief Summary

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The respiratory sleep disorders are a major cardiovascular risk factor. In fact there is enough scientific evidence that supports the association between apnea-hypopnea syndrome (SASH) and cardiovascular disease (hypertension, stroke, heart failure ....The objective of this study is to estimate the effectiveness of the continuous positive pressure airway (CPAP) in patient with chronic heart failure with normal ejection fraction but dyastolic dysfunction and sleep disordered breathing during the sleep.

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Detailed Description

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Conditions

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Heart Failure Sleep Respiratory Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Usual treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

CPAP

Treatment with CPAP

Group Type EXPERIMENTAL

CPAP

Intervention Type PROCEDURE

Treatment with CPAP

Interventions

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CPAP

Treatment with CPAP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Ejection fraction\> 45%, which also ruled out significant left ventricular dilation
2. At least two abnormal indices of diastolic function.

Exclusion Criteria

1. Not sinus rhytm
2. Severe lung disease (FEV1 or FVC less than 50%)
3. Significant valvular or congenital heart disease, primary
4. Unstable angina, myocardial infarction or cardiac surgery within three months prior to inclusion
5. Hypertrophic Cardiomyopathy
6. Presence of significant psychiatric disorders.
7. Severe Hypersomnia . (Epworth\> 20)
8. Severe pulmonary hypertension measured by Doppler,
9. Facial deformity and / or defect of nasal patency.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No