Evaluate the effectiveness of servo-ventilation therapy in patients with co-existing sleep related breathing disorders and heart failure [Evaluation de la BiPAP autoSV Advanced dans le traitement du syndrome d?apnées mixtes du sommeil chez les patients ayant une insuffisance cardiaque congestive]

Completed

• Conditions: Sleep related breathing disorders/heart failure; Nervous System Diseases; Sleep disorders

• Registration Number: ISRCTN26654460
• Lead Sponsor: Phillips Respironics International Inc. (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with heart failure and obstructive/central sleep apnoea (no specific age range or sex)
2. Naive patients to positive airway pressure therapy
3. Apnoea/Hypopnoea Index greater than 30/h with at least 30% of central events
4. Left ventricular ejection fraction less than 45%
5. Patients with a New York Heart Association (NYHA) class between II and IV
6. Stable and optimised medical cardiac therapy since one month at least
7. Informed consent signed

Exclusion Criteria

1. Patients with associated chronic obstructive pulmonary disease
2. Patients with unstable heart failure or stable since less than one month
3. Patients with unstable angina pectoris or stable since less than one month
4. Patients with stroke
5. Patients with ischaemic cardiomyopathy or cardiogenic oedema
6. Patients with a cardiac resynchronisation scheduled within the next 6 months
7. Patients with a valvular surgery scheduled within the next 6 months
8. Patients participating to another clinical trial or not affiliated to the social security system
9. Patients in jail or hospitalised without consent
10. Majors protected by the law or detainees
11. Minors
12. Pregnant or nursing women

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the correction of the apnoea/hypopnoea index (AHI); the method to evaluate this outcome will be the PSG recording.