Heart failure with sleep disordered breathing Circulatory System Heart failure
Conditions
Interventions
This is a randomised parallel, open-label trial with blinded evaluation of outcomes involving four centres of 12 weeks BiPAP autoSV™ and optimal medical management versus optimal medical management al
Sponsors
Respironics Inc. (USA)
Eligibility
Inclusion criteria
Inclusion criteria: 1. HF due to ischaemic, non-ischaemic or hypertensive cardiomyopathy diagnosed by a cardiologist 2. Aged 18 to 80 years 3. Impaired exercise capacity (New York Heart Association [NYHA] class II or III) 4. Objectively impaired left ventricular ejection fraction less than 40%, assessed by echocardiography 5. Stable clinical status and stable optimal medical therapy according to the guidelines of the European Society of Cardiology for at least four weeks 6. An AHI greater than or equal to 20 per hour of sleep assessed by in-laboratory polysomnography 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Unstable angina, myocardial infarction, cardiac surgery or hospital admissions within the previous three months 2. NYHA class I or IV 3. Pregnancy 4. Contraindications for BiPAP autoSV™: a. mean supine Blood Pressure [BP] less than 60 mmHg b. inability to clear secretions c. patients at risk for aspiration of gastric contents d. history of pneumothorax and/or pneumomediastinum e. a history of epistaxis f. causing pulmonary aspiration of blood 5. Patients on or with indication for oxygen therapy 6. Severe restrictive and obstructive airways disease 7. HF due to primary valve disease 8. Awaiting heart transplant 9. Inability or unwillingness to provide written informed consent 10. Diurnal symptoms of SDB requiring immediate treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction, measured at baseline and three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Six-minute walk test 2. Borg Scale 3. Minnesota Living with Heart Failure Questionnaire (MLHFQ) 4. Functional Outcomes of Sleep Questionnaire (FOSQ) 5. 36-item Short Form health survey (SF-36) 6. Fatigue severity scale 7. Epworth sleepiness scale 8. The Apnoea-Hypopnoea Index (AHI) 9. Obstructive AHI 10. Central AHI 11. Mean oxygen saturation 12. Daytime activity 13. Glomerular filtration rate 14. B-type natriuretic peptide cardiopulmonary exercise test All secondary outcomes measured at baseline and three months. | — |
Countries
Canada, France, Germany, United Kingdom
Outcome results
None listed