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
  Purpose

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 Intervention
Heart Failure
Sleep Respiratory Disorders
Procedure: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • 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 ]

Enrollment: 420
Study Start Date: September 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual treatment
Experimental: CPAP
Treatment with CPAP
Procedure: CPAP
Treatment with CPAP

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Carlos Javier Egea Santaolalla, Hospital Txagorritxu
ClinicalTrials.gov Identifier: NCT01347411     History of Changes
Other Study ID Numbers: DIDAS
Study First Received: April 13, 2011
Last Updated: May 3, 2011
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
Sleep Apnea Syndromes
Heart Diseases
Cardiovascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014