French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Multicentre Observational French Cohort Study of Patients With Heart Failure and Central Sleep Apnoea Requiring Adaptive Servo-Ventilation (PaceWave, AutoSet CS) Treatment

Conditions
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Chronic Heart Failure, Central Sleep Apnea

Intervention / Treatment
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* Device: ASV Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASV Treatment<br>AutoSet CS, PaceWave | Device: ASV Treatment<br> <br> * Other names: AutoSet CS;|
| Control<br>No ASV treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to first event of all cause mortality or all cause hospitalization |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until death |  | 2 years | 
| Time to non cardiovascular death |  | 2 years | 
| Time to cardiovascular death |  | 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 | 
| Time to hospitalization for cardiovascular cause or cardiovascular death |  | 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 LVEF (Left Ventricular Ejection Fraction) as compared to baseline |  | 2 years | 
| Changes in Heart Rhythm as compared to baseline |  | 2 years | 
| Changes in Systolic and diastolic Blood Pressure |  | 2 years | 
| Changes in AHI (Apnea Hypopnea Index) as compared to baseline |  | 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 | 2 years | 
| Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline |  | 2 years | 
| Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline |  | 2 years | 
| ASV Compliance |  | 2 years | 
| Changes in medical treatment as compared to baseline | Medication consumption and use of cardiac implant will be reported | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, Central Sleep Apnea, Sleep-Disordered Breathing