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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Sleep Respiratory Disorders
• Intervention / Treatment: Procedure: CPAP

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Usual treatment
EXPERIMENTAL: CPAP; Treatment with CPAP	Procedure: CPAP; Treatment with CPAP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Basque Health Service

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (ESTIMATE): May 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 4, 2011
• Last Update Submitted That Met QC Criteria: May 3, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Heart Failure; Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: DIDAS