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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASV Treatment | AutoSet CS, PaceWave |
| |
| Control | No ASV treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASV Treatment | Device |
|
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time until death | 2 years | |
| Time to non cardiovascular death | 2 years | |
| Time to cardiovascular death |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic Heart Failure Patients with Central Sleep Apnea
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Pia d'ORTHO, MD, PhD | APHP (Assistance Publique Hôpitaux de Paris) - Bichat-Claude Bernard Hospital, Paris | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical practice of cardiology | Amnéville | 57360 | France | |||
| Angers University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37612192 | Derived | Tamisier R, Damy T, Bailly S, Goutorbe F, Davy JM, Lavergne F, Palot A, Verbraecken JA, d'Ortho MP, Pepin JL; FACE investigators; Steering committee members; d'Ortho MP, Pepin JL, Davy JM, Damy T, Tamisier R; FACE study investigators. FACE study: 2-year follow-up of adaptive servo-ventilation for sleep-disordered breathing in a chronic heart failure cohort. Sleep Med. 2024 Jan;113:412-421. doi: 10.1016/j.sleep.2023.07.014. Epub 2023 Jul 22. | |
| 32690535 |
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| 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 |
| Angers |
| 49100 |
| France |
| Antibes Hospital | Antibes | 06160 | France |
| Béziers Hospital | Béziers | 34500 | France |
| Cannes Hospital | Cannes | 06400 | France |
| Henri-Mondor University Hospital | Créteil | 94000 | France |
| Grenoble University Hospital | Grenoble | 38000 | France |
| Le Mans Hospital | Le Mans | 72037 | France |
| HCL - Croix-Rousse Hospital | Lyon | 69004 | France |
| Jacques Cartier Hospital | Massy | 91300 | France |
| Arnaud de Villeneuve University Hospital | Montpellier | 34000 | France |
| Nevers Hospital | Nevers | 58033 | France |
| APHP - Pitié-Salpêtrière University Hospital | Paris | 75013 | France |
| APHP - Bichat-Claude Bernard Hospital | Paris | 75018 | France |
| Bordeaux University Hospital | Pessac | 33604 | France |
| Poitiers University Hospital | Poitiers | 86021 | France |
| Saint Laurent Polyclinic | Rennes | 35706 | France |
| Toulouse University Hospital | Toulouse | 31000 | France |
| Derived |
| Tamisier R, Damy T, Davy JM, Verbraecken JA, Bailly S, Lavergne F, Palot A, Goutorbe F, Pepin JL, d'Ortho MP. Cohort profile: FACE, prospective follow-up of chronic heart failure patients with sleep-disordered breathing indicated for adaptive servo ventilation. BMJ Open. 2020 Jul 19;10(7):e038403. doi: 10.1136/bmjopen-2020-038403. |
| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| D006333 | Heart Failure |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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