Clinical trial NCT01831128: French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Central Sleep Apnea
Keywords: Congestive Heart Failure
Central Sleep Apnea
Sleep-Disordered Breathing
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Heart Failure Patients with Central Sleep Apnea

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.

Eligibility 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

Primary outcomes:
measure: Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure
timeFrame: 2 years
measure: Time to first event of cardiovascular mortality or unplanned hospitalization for worsening heart failure
timeFrame: 2 years
measure: Time to first event of all cause mortality or all cause hospitalization
timeFrame: 2 years
Secondary outcomes:
measure: Time until death
timeFrame: 2 years
measure: Time to non cardiovascular death
timeFrame: 2 years
measure: Time to cardiovascular death
timeFrame: 2 years
measure: Time to hospitalization due to deterioration of heart failure or cardiovascular death
timeFrame: 2 years
measure: Time to hospitalization for other reasons or death
timeFrame: 2 years
measure: Time to hospitalization for cardiovascular cause or cardiovascular death
timeFrame: 2 years
measure: Changes in CHF stage by evaluating NYHA (New York Heart Association) class as compared to baseline
timeFrame: 2 years
measure: Changes in Quality Of Life by measuring Minnesota score as compared to baseline
timeFrame: 2 years
measure: Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline
timeFrame: 2 years
measure: Changes in Heart Rhythm as compared to baseline
timeFrame: 2 years
measure: Changes in Systolic and diastolic Blood Pressure
timeFrame: 2 years
measure: Changes in AHI (Apnea Hypopnea Index) as compared to baseline
timeFrame: 2 years
measure: Changes in renal function as compared to baseline
timeFrame: 2 years
measure: Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline
timeFrame: 2 years
measure: Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline
timeFrame: 2 years
measure: ASV Compliance
timeFrame: 2 years
measure: Changes in medical treatment as compared to baseline
timeFrame: 2 years
Other outcomes:
Locations:
city: Amnéville
country: France
facility: Medical practice of cardiology
city: Angers
country: France
facility: Angers University Hospital
city: Antibes
country: France
facility: Antibes Hospital
city: Beziers
country: France
facility: Béziers Hospital
city: Cannes
country: France
facility: Cannes Hospital
city: Creteil
country: France
facility: Henri-Mondor University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Le Mans
country: France
facility: Le Mans Hospital
city: Lyon
country: France
facility: HCL - Croix-Rousse Hospital
city: Massy
country: France
facility: Jacques Cartier Hospital
city: Montpellier
country: France
facility: Arnaud de Villeneuve University Hospital
city: Nevers
country: France
facility: Nevers Hospital
city: Paris
country: France
facility: APHP - Pitié-Salpêtrière University Hospital
city: Paris
country: France
facility: APHP - Bichat-Claude Bernard Hospital
city: Pessac
country: France
facility: Bordeaux University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Saint Laurent Polyclinic
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: APHP (Assistance Publique Hôpitaux de Paris) - Bichat-Claude Bernard Hospital, Paris
name: Marie-Pia d'ORTHO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grenoble University Hospital, Grenoble
name: Jean-Louis PEPIN, MD, PhD
role: STUDY_CHAIR
affiliation: Arnaud de Villeneuve University Hospital, Montpellier
name: Jean-Marc DAVY, MD, PhD
role: STUDY_CHAIR
affiliation: APHP - Henri Mondor University Hospital, Creteil
name: Thibaud DAMY, MD, PhD
role: STUDY_CHAIR
affiliation: Grenoble University Hospital, Grenoble
name: Patrick LEVY, MD, PhD
role: STUDY_CHAIR
affiliation: Grenoble University Hospital, Grenoble
name: Renaud TAMISIER, MD, PhD
role: STUDY_CHAIR
References:
citation: Tamisier R, Damy T, Davy JM, Verbraecken JA, Bailly S, Lavergne F, Palot A, Goutorbe F, Pepin JL, d'Ortho MP. Cohort profile: FACE, prospective follow-up of chronic heart failure patients with sleep-disordered breathing indicated for adaptive servo ventilation. BMJ Open. 2020 Jul 19;10(7):e038403. doi: 10.1136/bmjopen-2020-038403.