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Chronic Heart FailureFACENCT01831128

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

An observational study of Chronic Heart Failure and Central Sleep Apnea, run by ResMed at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure, Central Sleep Apnea
What is being tested?
ASV Treatment
Type of treatment
Medical device
How many people
509 participants
Where
18 sitesFrance
Study dates
Nov 2009to Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chronic Heart Failure Patients with Central Sleep Apnea

Who may be able to join

  • Adult Patient with Chronic Heart Failure
  • Central Sleep Apnea requiring ASV therapy

Who cannot join

  • Contra-indications to ASV therapy
  • Respiratory Failure or Hypercapnia inconsistent with ASV therapy

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Medical practice of cardiology

    Amnéville, 57360

  • Angers University Hospital

    Angers, 49100

  • Antibes Hospital

    Antibes, 06160

  • Béziers Hospital

    Béziers, 34500

  • Cannes Hospital

    Cannes, 06400

  • Henri-Mondor University Hospital

    Créteil, 94000

  • Grenoble University Hospital

    Grenoble, 38000

  • Le Mans Hospital

    Le Mans, 72037

  • HCL - Croix-Rousse Hospital

    Lyon, 69004

  • Jacques Cartier Hospital

    Massy, 91300

  • Arnaud de Villeneuve University Hospital

    Montpellier, 34000

  • Nevers Hospital

    Nevers, 58033

  • APHP - Pitié-Salpêtrière University Hospital

    Paris, 75013

  • APHP - Bichat-Claude Bernard Hospital

    Paris, 75018

  • Bordeaux University Hospital

    Pessac, 33604

  • Poitiers University Hospital

    Poitiers, 86021

  • Saint Laurent Polyclinic

    Rennes, 35706

  • Toulouse University Hospital

    Toulouse, 31000

Other trials in France

About this study

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

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).

Read the 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.

Being tested
ASV Treatment
Keywords
Congestive Heart Failure, Central Sleep Apnea, Sleep-Disordered Breathing
Medical subject headings
Sleep Apnea, Central, Heart Failure, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASV TreatmentDevice

    Also called PaceWave, AutoSet CS

Study groups in NCT01831128
Study groupRoleWhat they receive
ASV TreatmentAutoSet CS, PaceWave
Receives: Device: ASV Treatment
ControlNo ASV treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure

    Measured: 2 years

  2. Time to first event of cardiovascular mortality or unplanned hospitalization for worsening heart failure

    Measured: 2 years

  3. Time to first event of all cause mortality or all cause hospitalization

    Measured: 2 years

Secondary outcomes (17)

  1. Time until death

    Measured: 2 years

  2. Time to non cardiovascular death

    Measured: 2 years

  3. Time to cardiovascular death

    Measured: 2 years

  4. Time to hospitalization due to deterioration of heart failure or cardiovascular death

    Measured: 2 years

  5. Time to hospitalization for other reasons or death

    Measured: 2 years

  6. Time to hospitalization for cardiovascular cause or cardiovascular death

    Measured: 2 years

  7. Changes in CHF stage by evaluating NYHA (New York Heart Association) class as compared to baseline

    Measured: 2 years

  8. Changes in Quality Of Life by measuring Minnesota score as compared to baseline

    Measured: 2 years

  9. Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline

    Measured: 2 years

  10. Changes in Heart Rhythm as compared to baseline

    Measured: 2 years

  11. Changes in Systolic and diastolic Blood Pressure

    Measured: 2 years

  12. Changes in AHI (Apnea Hypopnea Index) as compared to baseline

    Measured: 2 years

  13. Changes in renal function as compared to baseline

    Estimated GFR (eGFR) will be calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula

    Measured: 2 years

  14. Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline

    Measured: 2 years

  15. Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline

    Measured: 2 years

  16. ASV Compliance

    Measured: 2 years

  17. Changes in medical treatment as compared to baseline

    Medication consumption and use of cardiac implant will be reported

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2013 (estimated)
  2. Study startNov 2009
  3. Primary completionSep 2020
  4. Study completionSep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831128
Sponsor's protocol ID
FACE 001
Acronym
FACE
Status last verified
Feb 2021
First submitted
2 Apr 2013
Last updated
2 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • Tamisier R, Damy T, Bailly S, Goutorbe F, Davy JM, Lavergne F, Palot A, Verbraecken JA, d'Ortho MP, Pepin JL; FACE investigators; Steering committee members; d'Ortho MP, Pepin JL, Davy JM, Damy T, Tamisier R; FACE study investigators. FACE study: 2-year follow-up of adaptive servo-ventilation for sleep-disordered breathing in a chronic heart failure cohort. Sleep Med. 2024 Jan;113:412-421. doi: 10.1016/j.sleep.2023.07.014. Epub 2023 Jul 22.

    PubMed 37612192

  • 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.

    PubMed 32690535

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Heart Failure and Central Sleep Apnea, run by ResMed at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831128, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.

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