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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347411
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : May 4, 2011
Information provided by:
Basque Health Service

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.

Condition or disease Intervention/treatment
Heart Failure Sleep Respiratory Disorders Procedure: CPAP

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2007
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Usual treatment
Experimental: CPAP
Treatment with CPAP
Procedure: CPAP
Treatment with CPAP

Primary Outcome Measures :
  1. number of patients without diastolic dysfunction [ Time Frame: One year ]
    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

  2. number of hospital admissions for any cause [ Time Frame: One year ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Carlos Javier Egea Santaolalla, Hospital Txagorritxu Identifier: NCT01347411     History of Changes
Other Study ID Numbers: DIDAS
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases