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

Completed

• Conditions: Central Sleep Apnea; Chronic Heart Failure

• Registration Number: NCT01831128
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-15
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first event of all cause mortality or all cause hospitalization	2 years
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

Secondary Outcome Measures

Name	Time	Method
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 BNP (B-type Natriuretic Peptide) rates as compared to baseline	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
Changes in Systolic and diastolic Blood Pressure	2 years
Changes in AHI (Apnea Hypopnea Index) as compared to baseline	2 years
Time until death	2 years
Time to non cardiovascular death	2 years
Time to cardiovascular death	2 years
Time to hospitalization for cardiovascular cause or cardiovascular death	2 years
Changes in Heart Rhythm as compared to baseline	2 years
Changes in renal function as compared to baseline	2 years	Estimated GFR (eGFR) will be calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula
Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline	2 years
Changes in medical treatment as compared to baseline	2 years	Medication consumption and use of cardiac implant will be reported
Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline	2 years
ASV Compliance	2 years

Trial Locations

Locations (18)

Medical practice of cardiology; 🇫🇷 Amnéville, France

Angers University Hospital; 🇫🇷 Angers, France

Antibes Hospital; 🇫🇷 Antibes, France

Béziers Hospital; 🇫🇷 Beziers, France

Cannes Hospital; 🇫🇷 Cannes, France

Henri-Mondor University Hospital; 🇫🇷 Creteil, France

Grenoble University Hospital; 🇫🇷 Grenoble, France

Le Mans Hospital; 🇫🇷 Le Mans, France

HCL - Croix-Rousse Hospital; 🇫🇷 Lyon, France

Jacques Cartier Hospital; 🇫🇷 Massy, France

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