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 Overview
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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.

Official Title
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Effectiveness of the Treatment With CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing

Conditions
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Heart Failure, Sleep Respiratory Disorders

Intervention / Treatment
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* Procedure: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ejection fraction> 45%, which also ruled out significant left ventricular dilation At least two abnormal indices of diastolic function. Exclusion Criteria: Not sinus rhytm Severe lung disease (FEV1 or FVC less than 50%) Significant valvular or congenital heart disease, primary Unstable angina, myocardial infarction or cardiac surgery within three months prior to inclusion Hypertrophic Cardiomyopathy Presence of significant psychiatric disorders. Severe Hypersomnia . (Epworth> 20) Severe pulmonary hypertension measured by Doppler, Facial deformity and / or defect of nasal patency.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual treatment | |
| Experimental: CPAP<br>Treatment with CPAP | Procedure: CPAP<br>* Treatment with CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients without diastolic dysfunction | number of patient without diastolic dysfunction defined by any of this parametres: TRI (isovolumetric relaxation time):> 105 ms (> 50 years),> 100 ms (30-50 years). 2. Wave ratio E / A wave <1 and deceleration time> 220 ms (under 50) and E / A <0.5 and deceleration time> 280 ms (50 +). 3. Relationship between systolic and diastolic wave flow following pulmonary vein (S / D): S / D> 1.5 (under 50) and S / D> 2.5 (over 50). A wave velocity of pulmonary venous flow> 35 cm / s. Flow propagation velocity by color M-mode <45 cm / s. E wave peak velocity by DTI of the ring: Em <5 cm / s | One year | 
| number of hospital admissions for any cause |  | One year |