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Completed

NCT Number: NCT01347411

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Sleep Respiratory Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cPAP

Procedure

Treatment with CPAP

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 4, 2011
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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