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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347411
• Other study ID #: DIDAS
• Status: Completed
• Phase: N/A
• First received: April 13, 2011
• Last updated: May 3, 2011
• Start date: September 2007
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Respiration Disorders
• Respiratory Tract Diseases
• Sleep Respiratory Disorders

Intervention

Procedure:
• CPAP
Treatment with CPAP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	number of hospital admissions for any cause		One year	No