Sleep Apnea and Atrial Fibrillation Recurrence (SAAFIR)

March 19, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Effect of Sleep Apnea Screening and Treatment on Atrial Fibrillation Recurrence : a Randomized Controlled Trial

The main aim of this project is to assess the effect of Sleep apnea syndrome (SAS) screening (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index >15 / h) on recurrence of atrial fibrillation (AF) over a twenty-four month follow-up period, in patients on optimal medical treatment after AF ablation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sleep apnea syndrome (SAS) is a common but often undiagnosed disorder associated with substantial cardiovascular morbidity and mortality. SAS prevalence in atrial fibrillation (AF) is 20% to 75%. SAS is associated with both myocardial fibrosis and electrical remodeling which both favor recurrence of AF despite medical treatment or atrial ablation. Proportion of patients with SAS are higher in patients with high-frequency paroxysmal AF and persistent AF than those with low frequency paroxysmal AF. Furthermore, untreated SAS doubles the risk of recurrence of AF after electrical cardioversion. Noteworthy, up to now, given the large number of potential candidates, not all patients with AF are screened for SAS despite recent international guidelines.

Observational studies suggest that treatment of SAS can prevent recurrence of AF episodes but no randomised trial demonstrate this with an adequate level of evidence. In addition, SAS treatment with continuous positive airway pressure (CPAP) has proven its efficacy on other pathologies on cardiovascular outcomes as stroke and to a lesser extend hypertension. In several countries including France, CPAP is reimbursed by national health services. However there are few data on the cost effectiveness of SAS treatment from the standpoint of cardiovascular health costs and no study in AF. Limits of small randomized studies and observational cohorts are fairly illustrated by very recent results of a randomized trial, the SERVE-HF study, which raised the question of central SAS treatment on mortality in systolic heart failure patients. This multicentre randomized trial showed no difference in global mortality between groups, with even an increased OR for cardiovascular death in patients treated for central SAS. In this context, the need of a randomized trial in AF, with a data safety and monitoring board, is even more important to confirm results of observational studies.

Our hypothesis is that SAS screening (and SAS-treatment if screening is positive) in patients presenting with recurrent AF will decrease the risk of recurrence of AF, therefore decreasing associated health costs.

SAS is largely under-diagnosed in AF patients and screening is recommended despite lack of high level-evidences on efficacy of SAS treatment on AF recurrence, and still low resources in terms of SAS screening and absence of cost-effectiveness analysis.

The investigators propose a study design in which patients are randomized for SAS screening in two groups :

  • the control group will receive usual care and follow-up of AF;
  • the intervention group will benefit of screening for SAS and treatment if relevant (moderate to severe SAS defined by an apnea hypopnea index (AHI)> 15/h), in addition to usual treatment of AF.

The cost-effectiveness of a systematic screening for SAS in AF has never been studied despite the personal and economic burden of SAS treatment. The investigators will analyze the consequences on direct medical costs of systematic SAS screening and treatment in the patients with AF and whether SAS therapy would decrease healthcare resource utilization and costs, via decreasing AF recurrence.

The main aim of this project is to assess the effect of SAS screening (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index >15 / h) on recurrence of AF over a twenty-four month follow-up period, in patients on optimal medical treatment after AF ablation.

A 2 group parallel, randomized (1:1 ratio), Prospective Open Blinded Endpoint (PROBE), multicentric controlled trial of superiority.

The control group will receive usual care and follow-up of AF. The intervention group will benefit of screening of SAS and treatment if relevant, in addition to usual treatment of AF.

To minimize cross over from the control to the intervention group, patients of the control group will performed a polygraph at the end of the 2 year follow up. Both groups will be stratified by center.

SAS diagnosis will be performed by polygraphy scored using international criteria (American Academy of Sleep Medicine 2012). If AHI > 15/h, treatment will be started, with continuous positive airway pressure (CPAP) or mandibular repositioning device (MRD) based on type and severity of SAS.

Both groups will be followed over 24 months by the cardiologist, and by the somnologist / pulmonologist for the patients treated for SAS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Hopital Bichat-Claude Bernard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria :

  • Patients experiencing at least a second episode of symptomatic and documented atrial fibrillation (paroxysmal or persistent) within the preceding 12 months, unrelated to an acute cause, considered to be appropriate candidates for rhythm-control therapy (catheter ablation therapy)
  • Age >18 y and < 80y
  • Expected hospitalization for atrial fibrillation ablation

Exclusion criteria :

  • Already known SAS,
  • Severe sleepiness (Epworth sleepiness score > 14)
  • Driving professional
  • Severe Chronic obstructive pulmonary disease (COPD)
  • Any other illness susceptible to shorten life expectancy within the study duration.
  • Previous ablation for atrial fibrillation,
  • Secondary atrial fibrillation (due to cardiac surgery, infection, or hyperthyroidism).
  • Severe heart failure (NYHA functional class III to IV),
  • Expected surgery for structural heart disease
  • Unable to understand and to comply to clinical research procedures,
  • Not covered by the national health insurance system
  • No consenting for a randomised controlled trial
  • Previous exam missing
  • Pregnancy and breast feeding
  • Guardianship or trusteeship patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Just after AF ablation, nocturnal polygraphy will be performed to diagnose SAS. If present and AHI >15/h, the SAS will be treated, based on type and severity of SAS and on patient tolerance to treatment.
Other: Intervention group
Just after AF ablation, nocturnal polygraphy will be performed to diagnose SAS. If present and AHI >15/h, the SAS will be treated, based on type and severity of SAS and on patient tolerance to treatment.
Other Names:
  • SAS screening
No Intervention: Control group
No SAS screening will be performed in this group before the end of the 2 year follow up period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to recurrence of AF after AF ablation.
Time Frame: 24 month
To assess the effect of SAS screening (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index > 15 / h) on recurrence of AF over a twenty-four month follow-up period, in patients on optimal medical treatment after AF ablation.
24 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost utility analysis of SAS screening by reporting health resource utilization
Time Frame: 24 month
24 month
Measure of health status EQ-5D
Time Frame: 24 month
Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status
24 month
Number of cardioversions
Time Frame: 24 month
24 month
Number of radiofrequency catheter ablation
Time Frame: 24 month
24 month
AF burden
Time Frame: 24 month
ratio of the time spent in AF during the 2 weeks-simplified auto-trigger Holter ECG to the total recording time from the 3 month blanking period following the AF ablation to the end of the 24 month observation period.
24 month
Number of hospitalisations for cardiovascular reasons
Time Frame: 24 month
24 month
Number of hospitalisations for any causes
Time Frame: 24 month
24 month
Number of incident cardiovascular events
Time Frame: 24 month
Number of incident cardiovascular events: stroke, acute coronary syndrome, transient ischaemic attacks, ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina, sudden cardiac death, peripheral vascular ischaemia, pulmonary embolism
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Pia d'ORTHO, Pr MD PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P150928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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