Condition category
Nervous System Diseases
Date applied
08/04/2010
Date assigned
22/04/2010
Last edited
01/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean-Louis Pepin

ORCID ID

Contact details

Pôle de Rééducation et Physiologie
Laboratoire d’Exploration Fonctionnelles Cardio-Respiratoires et Laboratoire du Sommeil
CHU de Grenoble
BP 217
Grenoble
38043
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAME09ASV01

Study information

Scientific title

Evaluate the effectiveness of servo-ventilation therapy in patients with co-existing sleep related breathing disorders and heart failure: a 6-month longitudinal case-control observational study

Acronym

Study hypothesis

Servo-ventilation therapy may improve the quality of life and prognosis in patients with co-existing sleep disordered breathing and heart failure. This is an observational trial where we would like to follow up a group of such patients and to evaluate the outcomes.

Ethics approval

Comité de Protection des Personnes Sud Est V approved on the 13th May 2009 (ref: CPP 09-RESP-1)

Study design

Observational longitudinal case-control multicentre study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sleep related breathing disorders/heart failure

Intervention

After checking inclusion/exclusion criterias and having the patient consent signed, the following steps will be as follows:

1. First Visit (V0):
1.1. Polysomnography (PSG) diagnostic night
1.2. Clinical evaluation
1.3. Arterial and blood review
1.4. Cardiac evaluation
1.5. PSG control night

2. Second Visit at 10 days (V1):
2.1. Clinical evaluation
2.2. Blood pressure measurement
2.3. Questionnaires
2.4. Device compliance download
2.5. Polygraphy ambulatory recording

3. Third Visit at 1 month (V2):
3.1. Clinical evaluation
3.2. Blood pressure measurement
3.3. Questionnaires
3.4. Device compliance download

4. Fourth Visit at 3 months (V3):
4.1. Clinical evaluation
4.2. Blood pressure measurement
4.3. Questionnaires
4.4. Device compliance download
4.5. Effort test
4.6. Walking test
4.7. Blood gases/NTProBNP

5. Fifth Visit at 6 months (V4):
5.1. Clinical evaluation
5.2. Blood pressure measurement
5.3. Questionnaires
5.4. Device compliance download
5.5. Scan or isotope imaging
5.6. Effort test
5.7. Measuring the ventilatory response to CO2
5.8. Walking test
5.9. Blood gases/determination of NT-proBNP
5.10. PSG control night

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Assess the correction of the apnoea/hypopnoea index (AHI); the method to evaluate this outcome will be the PSG recording.

Secondary outcome measures

1. Cardiovascular function: assessing long-term changes in left ventricular ejection fraction (LVEF) when using the in BiPAP autoSV Advanced:
1.1. LVEF: assessed by measuring Scan or Isotope imaging
1.2. Left Ventricular Diastolic Function (FDVG)
1.3. Determination of NT-proBNP

2. Improvement of cardiorespiratory function in BiPAP autoSV Advanced:
2.1. Effort Test: measurement of oxygen consumption (VO2max), ventilatory threshold value, ventilatory response to CO2 (VE/VCO2)
2.2. Six-minute walk Test: to assess the distance in meters, heart rate and SaO2 at the end of trial
2.3. PSG: blood average oxygen Saturation (SaO2) and oxygen desaturation index per hour of sleep. The desaturation threshold is set at 3%. In addition, we calculate the time spent with SaO2 <90%

3. Quality of sleep:
3.1. Total time of sleep (in minutes)
3.2. Percentage of REM sleep, slow wave sleep light (I and II), and slow deep (III and IV)
3.3. Index of arousal associated with respiratory events per hour

4. Effectiveness of sleep: ratio of total sleep time and time spent in bed

5. Questionnaires:
5.1. Daytime sleepiness: Epworth Sleepiness Questionnaire (QSE)
5.2. Quality of life Questionnaire Minnesota

6. Acceptance rate expressed by:
6.1. Compliance of more than 4 hours
6.2. Percentage of patients continuing their treatment at 6 months

Overall trial start date

10/04/2010

Overall trial end date

10/04/2011

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

1. Patients with heart failure and obstructive/central sleep apnoea (no specific age range or sex)
2. Naive patients to positive airway pressure therapy
3. Apnoea/Hypopnoea Index greater than 30/h with at least 30% of central events
4. Left ventricular ejection fraction less than 45%
5. Patients with a New York Heart Association (NYHA) class between II and IV
6. Stable and optimised medical cardiac therapy since one month at least
7. Informed consent signed

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Patients with associated chronic obstructive pulmonary disease
2. Patients with unstable heart failure or stable since less than one month
3. Patients with unstable angina pectoris or stable since less than one month
4. Patients with stroke
5. Patients with ischaemic cardiomyopathy or cardiogenic oedema
6. Patients with a cardiac resynchronisation scheduled within the next 6 months
7. Patients with a valvular surgery scheduled within the next 6 months
8. Patients participating to another clinical trial or not affiliated to the social security system
9. Patients in jail or hospitalised without consent
10. Majors protected by the law or detainees
11. Minors
12. Pregnant or nursing women

Recruitment start date

10/04/2010

Recruitment end date

10/04/2011

Locations

Countries of recruitment

France

Trial participating centre

Pôle de Rééducation et Physiologie
Grenoble
38043
France

Sponsor information

Organisation

Phillips Respironics International Inc. (France)

Sponsor details

2 rue du château de Bel Air
Carquefou
44470
France

Sponsor type

Industry

Website

http://www.medical.philips.com/main/homehealth/index.wpd

Funders

Funder type

Industry

Funder name

Phillips 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

Publication citations

Additional files

Editorial Notes