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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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ResMed

Status

Completed

Conditions

Chronic Heart Failure
Central Sleep Apnea

Treatments

Device: ASV Treatment

Study type

Observational

Funder types

Industry

Identifiers

NCT01831128
FACE 001

Details and patient eligibility

About

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).

Full 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.

Enrollment

509 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

509 participants in 2 patient groups

ASV Treatment
Description:
AutoSet CS, PaceWave
Treatment:
Device: ASV Treatment
Control
Description:
No ASV treatment

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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