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

Basque Health Service

Status: Completed

Conditions: Sleep Respiratory Disorders; Heart Failure

Treatments: Procedure: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01347411

DIDAS

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Control

No Intervention group

Description:

Usual treatment

CPAP

Experimental group

Description:

Treatment with CPAP

Treatment:

Procedure: CPAP