Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02906839 |
| Other study ID # |
P150928 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 27, 2017 |
| Est. completion date |
November 22, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
