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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure; Central Sleep Apnea
• Intervention / Treatment: Device: ASV Treatment

Detailed Description

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 (Actual): 509

Contacts and Locations

Study Locations

• France
  • Amnéville, France, 57360
    • Medical practice of cardiology
  • Angers, France, 49100
    • Angers University Hospital
  • Antibes, France, 06160
    • Antibes Hospital
  • Beziers, France, 34500
    • Beziers Hospital
  • Cannes, France, 06400
    • Cannes Hospital
  • Creteil, France, 94000
    • Henri-Mondor University Hospital
  • Grenoble, France, 38000
    • Grenoble University Hospital
  • Le Mans, France, 72037
    • Le Mans Hospital
  • Lyon, France, 69004
    • HCL - Croix-Rousse Hospital
  • Massy, France, 91300
    • Jacques Cartier Hospital
  • Montpellier, France, 34000
    • Arnaud de Villeneuve University Hospital
  • Nevers, France, 58033
    • Nevers Hospital
  • Paris, France, 75013
    • APHP - Pitié-Salpêtrière University Hospital
  • Paris, France, 75018
    • APHP - Bichat-Claude Bernard Hospital
  • Pessac, France, 33604
    • Bordeaux University Hospital
  • Poitiers, France, 86021
    • Poitiers University Hospital
  • Rennes, France, 35706
    • Saint Laurent Polyclinic
  • Toulouse, France, 31000
    • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic Heart Failure Patients with Central Sleep Apnea

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASV Treatment; AutoSet CS, PaceWave	Device: ASV Treatment; Other Names: AutoSet CS; PaceWave
Control; No ASV treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2009
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 9, 2013
• First Posted (ESTIMATE): April 15, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Congestive Heart Failure; Sleep-Disordered Breathing; Central Sleep Apnea
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Heart Failure; Sleep Apnea Syndromes; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: FACE 001