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

Chronic Heart Failure Clinical Trial

— FACE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831128
• Other study ID #: FACE 001
• Status: Completed
• Start date: November 2009
• Est. completion date: September 2020

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Chronic Heart Failure
• Heart Failure
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

Device:
• ASV Treatment

Locations

Country	Name	City	State
France	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	Arnaud de Villeneuve University Hospital	Montpellier
France	Nevers Hospital	Nevers
France	APHP - Bichat-Claude Bernard Hospital	Paris
France	APHP - Pitié-Salpêtrière University Hospital	Paris
France	Bordeaux University Hospital	Pessac
France	Poitiers University Hospital	Poitiers
France	Saint Laurent Polyclinic	Rennes
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure		2 years
Primary	Time to first event of cardiovascular mortality or unplanned hospitalization for worsening heart failure		2 years
Primary	Time to first event of all cause mortality or all cause hospitalization		2 years
Secondary	Time until death		2 years
Secondary	Time to non cardiovascular death		2 years
Secondary	Time to cardiovascular death		2 years
Secondary	Time to hospitalization due to deterioration of heart failure or cardiovascular death		2 years
Secondary	Time to hospitalization for other reasons or death		2 years
Secondary	Time to hospitalization for cardiovascular cause or cardiovascular death		2 years
Secondary	Changes in CHF stage by evaluating NYHA (New York Heart Association) class as compared to baseline		2 years
Secondary	Changes in Quality Of Life by measuring Minnesota score as compared to baseline		2 years
Secondary	Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline		2 years
Secondary	Changes in Heart Rhythm as compared to baseline		2 years
Secondary	Changes in Systolic and diastolic Blood Pressure		2 years
Secondary	Changes in AHI (Apnea Hypopnea Index) as compared to baseline		2 years
Secondary	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
Secondary	Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline		2 years
Secondary	Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline		2 years
Secondary	ASV Compliance		2 years
Secondary	Changes in medical treatment as compared to baseline	Medication consumption and use of cardiac implant will be reported	2 years