Randomised controlled trial of BiPAP autoSV™ therapy in patients with chronic heart failure and sleep-disordered breathing

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN04353156
• Date of registration: 16/05/2007
• Prospective Registration: No
• Primary sponsor: Respironics Inc. (USA)
• Public title: Randomised controlled trial of BiPAP autoSV™ therapy in patients with chronic heart failure and sleep-disordered breathing
• Date of first enrolment: 21/04/2007
• Target sample size: 70
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN04353156
• Study type: Interventional
• Study design: Randomised parallel open-label trial with blinded evaluation of outcomes (Treatment)

Countries of recruitment

Canada, France, Germany, United Kingdom

Contacts

• Name: Michael Pfeifer

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Heart failure with sleep disordered breathing
Circulatory System
Heart failure

Intervention(s)

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 alone. The BiPAP autoSV™ is intended to augment breathing by supplying pressurised air through a patient circuit. It senses the patient?s breathing effort by monitoring airflow in the patient circuit and adjusts its output to assist in inspiration and expiration. This assistance is provided by the administration of two levels of positive pressure. During expiration, pressure is variable positive or near ambient. During inspiration, pressure is variable positive and always higher than the expiratory level.

Primary Outcome(s)

Left ventricular ejection fraction, measured at baseline and three months.

Secondary Outcome(s)

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.

Secondary ID(s)

RI-SDBHF-2006-02

Source(s) of Monetary Support

Respironics International, Inc. (France)