Randomised controlled trial of BiPAP autoSV™ therapy in patients with chronic heart failure and sleep-disordered breathing
| ISRCTN | ISRCTN04353156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04353156 |
| Secondary identifying numbers | RI-SDBHF-2006-02 |
- Submission date
- 26/04/2007
- Registration date
- 16/05/2007
- Last edited
- 26/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michael Pfeifer
Scientific
Scientific
Klinik und Poliklinik fűr Innere Medizin II
University of Regensburg
Franz-Josef-Strauß-Allee 11
Regensburg
93042 Regensburg
Germany
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2008 |
Eligibility
| 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 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/04/2007 |
| Date of final enrolment | 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
93042 Regensburg
Germany
Sponsor information
Respironics Inc. (USA)
Industry
Industry
286 Site
1740 Golden Mile Highway
Monroeville
PA 15146-2094
United States of America
| Website | http://www.respironics.com/ |
|---|---|
"ROR" |
https://ror.org/03kw6wr76 |
Funders
Funder type
Industry
Respironics International, Inc. (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2013 | Yes | No |
