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

NCT01347411 | Completed

• 1 other identifier: DIDAS
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Sleep Respiratory Disorders

Outcome Measures

Primary Outcomes (2)

• number of patients without diastolic dysfunction

  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

  One year

• number of hospital admissions for any cause

  One year

Study Arms (2)

Control

NO INTERVENTION

Usual treatment

CPAP

EXPERIMENTAL

Treatment with CPAP

Procedure: CPAP

Interventions

CPAP PROCEDURE

Treatment with CPAP

CPAP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ejection fraction\> 45%, which also ruled out significant left ventricular dilation
• At least two abnormal indices of diastolic function.

You may not qualify if:

• Not sinus rhytm
• Severe lung disease (FEV1 or FVC less than 50%)
• Significant valvular or congenital heart disease, primary
• 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.

Sponsors & Collaborators

• Basque Health Service: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: May 4, 2011
• Study Start: September 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 4, 2011

Record last verified: 2011-04