French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)
- Conditions
- Central Sleep ApneaChronic Heart Failure
- Interventions
- Device: ASV Treatment
- Registration Number
- NCT01831128
- Lead Sponsor
- ResMed
- Brief Summary
The purpose of FACE study is to provide in routine practice complementary long-term data on the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea eligible for Adaptative Servo-Ventilation (ASV) treatment (PaceWave, AutoSet CS; ResMed).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 509
- Adult Patient with Chronic Heart Failure
- Central Sleep Apnea requiring ASV therapy
- Contra-indications to ASV therapy
- Respiratory Failure or Hypercapnia inconsistent with ASV therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ASV Treatment ASV Treatment AutoSet CS, PaceWave
- Primary Outcome Measures
Name Time Method Time to first event of all cause mortality or all cause hospitalization 2 years Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure 2 years Time to first event of cardiovascular mortality or unplanned hospitalization for worsening heart failure 2 years
- Secondary Outcome Measures
Name Time Method Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline 2 years ASV Compliance 2 years Changes in CHF stage by evaluating NYHA (New York Heart Association) class as compared to baseline 2 years Changes in Quality Of Life by measuring Minnesota score as compared to baseline 2 years Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline 2 years Time to hospitalization due to deterioration of heart failure or cardiovascular death 2 years Time to hospitalization for other reasons or death 2 years Changes in Systolic and diastolic Blood Pressure 2 years Changes in AHI (Apnea Hypopnea Index) as compared to baseline 2 years Time until death 2 years Time to non cardiovascular death 2 years Time to cardiovascular death 2 years Time to hospitalization for cardiovascular cause or cardiovascular death 2 years Changes in Heart Rhythm as compared to baseline 2 years Changes in renal function as compared to baseline 2 years Estimated GFR (eGFR) will be calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula
Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline 2 years Changes in medical treatment as compared to baseline 2 years Medication consumption and use of cardiac implant will be reported
Trial Locations
- Locations (18)
Angers University Hospital
🇫🇷Angers, France
Antibes Hospital
🇫🇷Antibes, France
Cannes Hospital
🇫🇷Cannes, France
Henri-Mondor University Hospital
🇫🇷Creteil, France
Arnaud de Villeneuve University Hospital
🇫🇷Montpellier, France
Bordeaux University Hospital
🇫🇷Pessac, France
Saint Laurent Polyclinic
🇫🇷Rennes, France
Poitiers University Hospital
🇫🇷Poitiers, France
Le Mans Hospital
🇫🇷Le Mans, France
APHP - Bichat-Claude Bernard Hospital
🇫🇷Paris, France
Toulouse University Hospital
🇫🇷Toulouse, France
Medical practice of cardiology
🇫🇷Amnéville, France
Nevers Hospital
🇫🇷Nevers, France
Béziers Hospital
🇫🇷Beziers, France
Jacques Cartier Hospital
🇫🇷Massy, France
Grenoble University Hospital
🇫🇷Grenoble, France
HCL - Croix-Rousse Hospital
🇫🇷Lyon, France
APHP - Pitié-Salpêtrière University Hospital
🇫🇷Paris, France