Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
RI-SDBHF-2006-02
Study information
Scientific title
Acronym
Study hypothesis
The application of BiPAP autoSV™ to patients with Heart Failure (HF) and Sleep Disordered Breathing (SDB) will:
1. Improve daytime left ventricular ejection fraction
2. Improve exercise capacity, daytime activity, daily symptoms of HF and SDB and oxygen saturation
3. Decrease both the central and obstructive component of the Apnoea-Hypopnoea Index (AHI), B-type natriuretic peptide levels and ventilation during exercise
Ethics approval(s)
This study has been approved by the ethics committees of all four sites:
1. Germany (Universty of Regensburg) - Protocol approved by the Ethikkommission an der Universitat Regensburg on 12th April 2007 (ref: 07/011)
2. UK (Prince Phillip Hospital) - Protocol approved by Dyfed Powys Local Research Ethics Committee on 2nd January 2007 (ref: 06/WMW01/57)
3. France (Clamart Hospital) - Protocol approved by the Comite de Protection des Personnes Il-de-France VII on 14th March 2007 (ref: 2007-A00014-49)
4. Canada (Hopital laval) - Protocol approved by the Comite d'ethique de la recherce de l'Hopital Laval on 11th April 2007 (ref: 20157)
Study design
Randomised parallel open-label trial with blinded evaluation of outcomes
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Heart failure with sleep disordered breathing
Intervention
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 patients 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.
Intervention type
Other
Primary outcome measure
Left ventricular ejection fraction, measured at baseline and three months.
Secondary outcome measures
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.
Overall study start date
21/04/2007
Overall study end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
80 Years
Sex
Not Specified
Target number of participants
70
Participant 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
Recruitment start date
21/04/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Canada, France, Germany, United Kingdom
Study participating centre
Klinik und Poliklinik fűr Innere Medizin II
Regensburg
93042 Regensburg
Germany
Sponsor information
Organisation
Respironics Inc. (USA)
Sponsor details
286 Site
1740 Golden Mile Highway
Monroeville
PA 15146-2094
United States of America
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Respironics International, Inc. (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2013 | Yes | No |