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
Protocol serial number RI-SDBHF-2006-02
Sponsor Respironics Inc. (USA)
Funder Respironics International, Inc. (France)
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

Klinik und Poliklinik fűr Innere Medizin II
University of Regensburg
Franz-Josef-Strauß-Allee 11
Regensburg
93042 Regensburg
Germany

Study information

Primary study designInterventional
Study designRandomised parallel open-label trial with blinded evaluation of outcomes
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesThe 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) studiedHeart failure with sleep disordered breathing
InterventionThis 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.
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(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.

Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexNot Specified
Target sample size at registration70
Key inclusion criteria1. 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 criteria1. 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 enrolment21/04/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • United Kingdom
  • Canada
  • France
  • Germany

Study participating centre

Klinik und Poliklinik fűr Innere Medizin II
Regensburg
93042 Regensburg
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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