French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)
NCT ID: NCT01831128
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
509 participants
OBSERVATIONAL
2009-11-30
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ASV Treatment
AutoSet CS, PaceWave
ASV Treatment
Control
No ASV treatment
No interventions assigned to this group
Interventions
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ASV Treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Central Sleep Apnea requiring ASV therapy
Exclusion Criteria
* Respiratory Failure or Hypercapnia inconsistent with ASV therapy
18 Years
ALL
No
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Principal Investigators
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Marie-Pia d'ORTHO, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
APHP (Assistance Publique Hôpitaux de Paris) - Bichat-Claude Bernard Hospital, Paris
Jean-Louis PEPIN, MD, PhD
Role: STUDY_CHAIR
Grenoble University Hospital, Grenoble
Jean-Marc DAVY, MD, PhD
Role: STUDY_CHAIR
Arnaud de Villeneuve University Hospital, Montpellier
Thibaud DAMY, MD, PhD
Role: STUDY_CHAIR
APHP - Henri Mondor University Hospital, Creteil
Patrick LEVY, MD, PhD
Role: STUDY_CHAIR
Grenoble University Hospital, Grenoble
Renaud TAMISIER, MD, PhD
Role: STUDY_CHAIR
Grenoble University Hospital, Grenoble
Locations
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Medical practice of cardiology
Amnéville, , France
Angers University Hospital
Angers, , France
Antibes Hospital
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
Arnaud de Villeneuve University Hospital
Montpellier, , France
Nevers Hospital
Nevers, , France
APHP - Pitié-Salpêtrière University Hospital
Paris, , France
APHP - Bichat-Claude Bernard Hospital
Paris, , France
Bordeaux University Hospital
Pessac, , France
Poitiers University Hospital
Poitiers, , France
Saint Laurent Polyclinic
Rennes, , France
Toulouse University Hospital
Toulouse, , France
Countries
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References
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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.
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.
Other Identifiers
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FACE 001
Identifier Type: -
Identifier Source: org_study_id
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