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

This study has been completed.

Sponsor:

Information provided by:

Basque Health Service

ClinicalTrials.gov Identifier:

NCT01347411

First received: April 13, 2011

Last updated: May 3, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 13, 2011
Last Updated Date	May 3, 2011
Start Date ^ICMJE	September 2007
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 3, 2011)	number of patients without diastolic dysfunction [ Time Frame: One year ] [ Designated as safety issue: No ] 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 [ Time Frame: One year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01347411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	Effectiveness of the Treatment With CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Heart Failure Sleep Respiratory Disorders
Intervention ^ICMJE	Procedure: CPAP Treatment with CPAP
Study Arm (s)	No Intervention: Control Usual treatment Experimental: CPAP Treatment with CPAP Intervention: Procedure: CPAP
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	420
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01347411
Other Study ID Numbers ^ICMJE	DIDAS
Has Data Monitoring Committee	No
Responsible Party	Carlos Javier Egea Santaolalla, Hospital Txagorritxu
Study Sponsor ^ICMJE	Basque Health Service
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Basque Health Service
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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