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
1 other identifier
observational
509
1 country
18
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2009
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 2, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFebruary 2, 2021
February 1, 2021
10.8 years
April 2, 2013
February 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (17)
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
- +12 more secondary outcomes
Study Arms (2)
ASV Treatment
AutoSet CS, PaceWave
Control
No ASV treatment
Interventions
Eligibility Criteria
Chronic Heart Failure Patients with Central Sleep Apnea
You may qualify if:
- Adult Patient with Chronic Heart Failure
- Central Sleep Apnea requiring ASV therapy
You may not qualify if:
- Contra-indications to ASV therapy
- Respiratory Failure or Hypercapnia inconsistent with ASV therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (18)
Medical practice of cardiology
Amnéville, 57360, France
Angers University Hospital
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
Related Publications (2)
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.
PMID: 37612192DERIVEDTamisier 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.
PMID: 32690535DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2013
First Posted
April 15, 2013
Study Start
November 1, 2009
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
February 2, 2021
Record last verified: 2021-02