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).
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
OBSERVATIONAL
Enrollment
509
Medical practice of cardiology
Amnéville, France
Angers University Hospital
Angers, France
Antibes Hospital
Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure
Time frame: 2 years
Time to first event of cardiovascular mortality or unplanned hospitalization for worsening heart failure
Time frame: 2 years
Time to first event of all cause mortality or all cause hospitalization
Time frame: 2 years
Time until death
Time frame: 2 years
Time to non cardiovascular death
Time frame: 2 years
Time to cardiovascular death
Time frame: 2 years
Time to hospitalization due to deterioration of heart failure or cardiovascular death
Time frame: 2 years
Time to hospitalization for other reasons or death
Time frame: 2 years
Time to hospitalization for cardiovascular cause or cardiovascular death
Time frame: 2 years
Changes in CHF stage by evaluating NYHA (New York Heart Association) class as compared to baseline
Time frame: 2 years
Changes in Quality Of Life by measuring Minnesota score as compared to baseline
Time frame: 2 years
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Antibes, France
Béziers Hospital
Béziers, France
Cannes Hospital
Cannes, France
Henri-Mondor University Hospital
Créteil, France
Grenoble University Hospital
Grenoble, France
Le Mans Hospital
Le Mans, France
HCL - Croix-Rousse Hospital
Lyon, France
Jacques Cartier Hospital
Massy, France
...and 8 more locations
Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline
Time frame: 2 years
Changes in Heart Rhythm as compared to baseline
Time frame: 2 years
Changes in Systolic and diastolic Blood Pressure
Time frame: 2 years
Changes in AHI (Apnea Hypopnea Index) as compared to baseline
Time frame: 2 years
Changes in renal function as compared to baseline
Estimated GFR (eGFR) will be calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula
Time frame: 2 years
Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline
Time frame: 2 years
Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline
Time frame: 2 years
ASV Compliance
Time frame: 2 years
Changes in medical treatment as compared to baseline
Medication consumption and use of cardiac implant will be reported
Time frame: 2 years