Condition category
Circulatory System
Date applied
26/04/2007
Date assigned
16/05/2007
Last edited
26/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Pfeifer

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Not specified

Trial 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 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

21/04/2007

Overall trial end date

31/12/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.respironics.com/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23222879

Publication citations

  1. Results

    Arzt M, Schroll S, Series F, Lewis K, Benjamin A, Escourrou P, Luigart R, Kehl V, Pfeifer M, Auto-servoventilation in heart failure with sleep apnoea: a randomised controlled trial., Eur. Respir. J., 2013, 42, 5, 1244-1254, doi: 10.1183/09031936.00083312.

Additional files

Editorial Notes