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Completed

NCT Number: NCT01831128

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical practice of cardiology, Amnéville, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASV Treatment

Device

Other names: PaceWave, AutoSet CS

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Prospective Multicentre Observational French Cohort Study of Patients With Heart Failure and Central Sleep Apnoea Requiring Adaptive Servo-Ventilation (PaceWave, AutoSet CS) Treatment

Acronym: FACE

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2013
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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