- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01831128
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS) (FACE)
Prospective Multicentre Observational French Cohort Study of Patients With Heart Failure and Central Sleep Apnoea Requiring Adaptive Servo-Ventilation (PaceWave, AutoSet CS) Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prevalence of Central Sleep Apnea (CSA) and/or Cheyne-Stokes Respiration (CSR) in patients with Chronic Heart Failure (HF) is 15-46% and it is associated with worse prognosis. Adaptative Servo-Ventilation (ASV) suppresses sleep apnoea and reduces hyperventilation, and is more effective than continuous positive airway pressure (CPAP) for treating CSA/CSR. Short-term studies show that ASV improves cardiac function and quality of life in CHF patients.
The SERVE HF multinational randomized trial is assessing the effects of addition of ASV (PaceWave, AutoSet CS; ResMed) to optimal medical management compared with medical management alone in symptomatic CHF patients with altered Left Ventricular Ejection Fraction and predominant CSA/CSR. The FACE study is a French prospective, multicentre, observational cohort that will provide complementary data to SERVE HF trial by characterizing CHF population eligible for ASV indications and evaluating the treatment management on long term follow-up of CHF patients with CSA/CSR in routine practice.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Amnéville, France, 57360
- Medical practice of cardiology
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Angers, France, 49100
- Angers University Hospital
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Antibes, France, 06160
- Antibes Hospital
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Beziers, France, 34500
- Beziers Hospital
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Cannes, France, 06400
- cannes Hospital
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Creteil, France, 94000
- Henri-Mondor University Hospital
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Grenoble, France, 38000
- Grenoble University Hospital
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Le Mans, France, 72037
- Le Mans hospital
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Lyon, France, 69004
- HCL - Croix-Rousse Hospital
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Massy, France, 91300
- Jacques Cartier Hospital
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Montpellier, France, 34000
- Arnaud de Villeneuve University Hospital
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Nevers, France, 58033
- Nevers Hospital
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Paris, France, 75013
- APHP - Pitié-Salpêtrière University Hospital
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Paris, France, 75018
- APHP - Bichat-Claude Bernard Hospital
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Pessac, France, 33604
- Bordeaux University Hospital
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Poitiers, France, 86021
- Poitiers University Hospital
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Rennes, France, 35706
- Saint Laurent Polyclinic
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Toulouse, France, 31000
- Toulouse University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult Patient with Chronic Heart Failure
- Central Sleep Apnea requiring ASV therapy
Exclusion Criteria:
- Contra-indications to ASV therapy
- Respiratory Failure or Hypercapnia inconsistent with ASV therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ASV Treatment
AutoSet CS, PaceWave
|
Other Names:
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Control
No ASV treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure
Time Frame: 2 years
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2 years
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Time to first event of cardiovascular mortality or unplanned hospitalization for worsening heart failure
Time Frame: 2 years
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2 years
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Time to first event of all cause mortality or all cause hospitalization
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time until death
Time Frame: 2 years
|
2 years
|
|
Time to non cardiovascular death
Time Frame: 2 years
|
2 years
|
|
Time to cardiovascular death
Time Frame: 2 years
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2 years
|
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Time to hospitalization due to deterioration of heart failure or cardiovascular death
Time Frame: 2 years
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2 years
|
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Time to hospitalization for other reasons or death
Time Frame: 2 years
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2 years
|
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Time to hospitalization for cardiovascular cause or cardiovascular death
Time Frame: 2 years
|
2 years
|
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Changes in CHF stage by evaluating NYHA (New York Heart Association) class as compared to baseline
Time Frame: 2 years
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2 years
|
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Changes in Quality Of Life by measuring Minnesota score as compared to baseline
Time Frame: 2 years
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2 years
|
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Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline
Time Frame: 2 years
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2 years
|
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Changes in Heart Rhythm as compared to baseline
Time Frame: 2 years
|
2 years
|
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Changes in Systolic and diastolic Blood Pressure
Time Frame: 2 years
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2 years
|
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Changes in AHI (Apnea Hypopnea Index) as compared to baseline
Time Frame: 2 years
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2 years
|
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Changes in renal function as compared to baseline
Time Frame: 2 years
|
Estimated GFR (eGFR) will be calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula
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2 years
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Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline
Time Frame: 2 years
|
2 years
|
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Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline
Time Frame: 2 years
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2 years
|
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ASV Compliance
Time Frame: 2 years
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2 years
|
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Changes in medical treatment as compared to baseline
Time Frame: 2 years
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Medication consumption and use of cardiac implant will be reported
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2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marie-Pia d'ORTHO, MD, PhD, APHP (Assistance Publique Hôpitaux de Paris) - Bichat-Claude Bernard Hospital, Paris
- Study Chair: Jean-Louis PEPIN, MD, PhD, Grenoble University Hospital, Grenoble
- Study Chair: Jean-Marc DAVY, MD, PhD, Arnaud de Villeneuve University Hospital, Montpellier
- Study Chair: Thibaud DAMY, MD, PhD, APHP - Henri Mondor University Hospital, Creteil
- Study Chair: Patrick LEVY, MD, PhD, Grenoble University Hospital, Grenoble
- Study Chair: Renaud TAMISIER, MD, PhD, Grenoble University Hospital, Grenoble
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FACE 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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