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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list