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

April 13, 2011
May 3, 2011
September 2007
April 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01347411 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Sleep Respiratory Disorders
Procedure: CPAP
Treatment with CPAP
  • No Intervention: Control
    Usual treatment
  • Experimental: CPAP
    Treatment with CPAP
    Intervention: Procedure: CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01347411
DIDAS
No
Carlos Javier Egea Santaolalla, Hospital Txagorritxu
Basque Health Service
Not Provided
Not Provided
Basque Health Service
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP