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

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ClinicalTrials.gov Identifier: NCT01831128
Recruitment Status : Recruiting
First Posted : April 15, 2013
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
ResMed

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).

Condition or disease Intervention/treatment
Chronic Heart Failure Central Sleep Apnea 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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicentre Observational French Cohort Study of Patients With Heart Failure and Central Sleep Apnoea Requiring Adaptive Servo-Ventilation (PaceWave, AutoSet CS) Treatment
Study Start Date : November 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure [ Time Frame: 2 years ]
  2. Time to first event of cardiovascular mortality or unplanned hospitalization for worsening heart failure [ Time Frame: 2 years ]
  3. Time to first event of all cause mortality or all cause hospitalization [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Time until death [ Time Frame: 2 years ]
  2. Time to non cardiovascular death [ Time Frame: 2 years ]
  3. Time to cardiovascular death [ Time Frame: 2 years ]
  4. Time to hospitalization due to deterioration of heart failure or cardiovascular death [ Time Frame: 2 years ]
  5. Time to hospitalization for other reasons or death [ Time Frame: 2 years ]
  6. Time to hospitalization for cardiovascular cause or cardiovascular death [ Time Frame: 2 years ]
  7. Changes in CHF stage by evaluating NYHA (New York Heart Association) class as compared to baseline [ Time Frame: 2 years ]
  8. Changes in Quality Of Life by measuring Minnesota score as compared to baseline [ Time Frame: 2 years ]
  9. Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline [ Time Frame: 2 years ]
  10. Changes in Heart Rhythm as compared to baseline [ Time Frame: 2 years ]
  11. Changes in Systolic and diastolic Blood Pressure [ Time Frame: 2 years ]
  12. Changes in AHI (Apnea Hypopnea Index) as compared to baseline [ Time Frame: 2 years ]
  13. Changes in renal function as compared to baseline [ Time Frame: 2 years ]
    Estimated GFR (eGFR) will be calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula

  14. Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline [ Time Frame: 2 years ]
  15. Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline [ Time Frame: 2 years ]
  16. ASV Compliance [ Time Frame: 2 years ]
  17. Changes in medical treatment as compared to baseline [ Time Frame: 2 years ]
    Medication consumption and use of cardiac implant will be reported



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic Heart Failure Patients with Central Sleep Apnea
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831128


Contacts
Contact: Laurent MORIN, PhD (0)426100200 ext 33 laurent.morin@resmed.fr

Locations
France
Medical practice of cardiology Recruiting
Amnéville Les thermes, France, 57360
Angers University Hospital Recruiting
Angers, France, 49100
Antibes Hospital Recruiting
Antibes, France, 06160
Béziers Hospital Recruiting
Beziers, France, 34500
Cannes Hospital Recruiting
Cannes, France, 06400
Henri-Mondor University Hospital Recruiting
Creteil, France, 94000
Grenoble University Hospital Recruiting
Grenoble, France, 38000
Le Mans Hospital Recruiting
Le Mans, France, 72037
HCL - Croix-Rousse Hospital Active, not recruiting
Lyon, France, 69004
Jacques Cartier Hospital Recruiting
Massy, France, 91300
Arnaud de Villeneuve University Hospital Recruiting
Montpellier, France, 34000
Nevers Hospital Recruiting
Nevers, France, 58033
APHP - Pitié-Salpêtrière University Hospital Recruiting
Paris, France, 75013
APHP - Bichat-Claude Bernard Hospital Recruiting
Paris, France, 75018
Principal Investigator: Marie-Pia d'ORTHO, MD, PhD         
Bordeaux University Hospital Recruiting
Pessac, France, 33604
Poitiers University Hospital Active, not recruiting
Poitiers, France, 86021
Saint Laurent Polyclinic Recruiting
Rennes, France, 35706
Toulouse University Hospital Recruiting
Toulouse, France, 31000
Sponsors and Collaborators
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

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01831128     History of Changes
Other Study ID Numbers: FACE 001
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by ResMed:
Congestive Heart Failure
Central Sleep Apnea
Sleep-Disordered Breathing

Additional relevant MeSH terms:
Heart Failure
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Central
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases