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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01347411

Enrollment

420

Registered

2011-05-04

Start date

2007-09-30

Completion date

2011-04-30

Last updated

2011-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Sleep Respiratory Disorders

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.

Interventions

PROCEDURECPAP

Treatment with CPAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
number of patients without diastolic dysfunction	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
number of hospital admissions for any cause	One year	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026