Back to resultsEffectiveness of the Treatment With Continuous Positive Airway Pressure(CPAP)in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing
Primary Purpose
Heart Failure, Sleep Respiratory Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
CPAP
Arm Description
Usual treatment
Treatment with CPAP
Outcomes
Primary Outcome Measures
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
number of hospital admissions for any cause
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01347411
Brief Title
Effectiveness of the Treatment With Continuous Positive Airway Pressure(CPAP)in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Basque Health Service
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Sleep Respiratory Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual treatment
Arm Title
CPAP
Arm Type
Experimental
Arm Description
Treatment with CPAP
Intervention Type
Procedure
Intervention Name(s)
CPAP
Intervention Description
Treatment with CPAP
Primary Outcome Measure Information:
Title
number of patients without diastolic dysfunction
Description
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
Time Frame
One year
Title
number of hospital admissions for any cause
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of the Treatment With Continuous Positive Airway Pressure(CPAP)in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing
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