Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000262404
Ethics application status
Approved
Date submitted
22/02/2016
Date registered
26/02/2016
Date last updated
26/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of obstructive sleep apnea treatment in patients with paroxysmal atrial fibrillation.
Scientific title
Impact of continuous positive airway pressure (CPAP) on freedom from arrhythmia in patients with obstructive Sleep apnea (OSA) and Atrial Fibrillation (AF).
Secondary ID [1] 288580 0
Nil
Universal Trial Number (UTN)
U1111-1179-8593
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 297712 0
Sleep Apnoea 297713 0
Condition category
Condition code
Cardiovascular 297897 297897 0 0
Other cardiovascular diseases
Respiratory 297898 297898 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a multi centre prospective randomised controlled trial that aims to evaluate the impact of continuous positive airway pressure (CPAP) for 1 year on atrial fibrillation (AF) burden in patients with obstructive sleep apnea (OSA).

Following diagnosis of at least moderate OSA, patients randomised to the treatment arm will commence CPAP therapy while patients in the control arm will not. CPAP therapy comprises a mask that is worn while sleeping that provides positive airway pressure. All patients randomized to CPAP therapy will receive CPAP education, hands-on demonstration, careful mask fitting and acclimatization prior to titration. Pressures are titrated in the range of 4-20cm H2O until obstructive events are eliminated or maximum CPAP is reach, based on present guidelines for OSA management. The number of visits required for pressure titration will be based on physician clinical judgement.

Patients will be followed at 3, 6, 9 and 12 months after enrolment into the study, to assess compliance, efficacy and symptoms. Patients in the control arm will also be followed at these time points for ongoing review.

CPAP adherence will be monitored by clinical evaluation and by utilising the remote monitoring function on CPAP machines.
Intervention code [1] 293969 0
Treatment: Devices
Comparator / control treatment
No treatment for OSA, i.e. no CPAP
Control group
Active

Outcomes
Primary outcome [1] 297417 0
Change in AF burden (as a percentage of time in AF) assessed by implanted loop recorder or Holter monitor.
Timepoint [1] 297417 0
3, 6, 9 and 12 months
Primary outcome [2] 297418 0
Change in AF burden (as total time in AF) assessed by implanted loop recorder or Holter monitor.
Timepoint [2] 297418 0
3, 6, 9 and 12 months
Secondary outcome [1] 320983 0
Cardiac Structure & Function: Composite outcome assessed using transthoracic echocardiographic measures of left and right atrial size, ventricular dimensions, ventricular hypertrophy, systolic function and diastolic function, including measurements of strain and torsion.
Timepoint [1] 320983 0
Baseline, 6 and 12 months
Secondary outcome [2] 320984 0
Sleep questionnaires: The Berlin Questionnaire, The Epworth Sleepiness Scale and the STOP-BANG questionnaires will be used to assess symptoms of sleep apnoea.
Timepoint [2] 320984 0
Baseline, 6 and 12 months
Secondary outcome [3] 320985 0
AF Symptom questionnaires: including Toronto AF severity scale and European Heart Rhythm Association AF symptom scale.
Timepoint [3] 320985 0
Baseline, 6 and 12 months
Secondary outcome [4] 320986 0
Digital ECG's to assess P wave duration and dispersion.
Timepoint [4] 320986 0
Baseline, 6 and 12 months
Secondary outcome [5] 320987 0
Inflammation, assessed by composite outcome of of high-sensitivity C-reactive protein (hs-CRP) and Tumour Necrosis Factor Alpha (TNF-a) from venous blood.
Timepoint [5] 320987 0
Baseline, 6 and 12 months
Secondary outcome [6] 320988 0
Profibrotic Markers: Composite outcome of Tissue Growth Factor (TGF-beta) and matrix metalloproteinase-9 (MMP-9) will be quantified as markers of fibrosis.
Timepoint [6] 320988 0
Baseline, 6 and 12 months
Secondary outcome [7] 320989 0
Composite outcome of platelet aggregation & thrombotic markers: Given the relationship between AF and embolic stroke, we will quantify circulating thrombotic (fibrinogen, plasminogen activator inhibitor 1) and fibrinolytic markers (tissue-plasminogen activator) and 2) platelet aggregation from venous blood samples collected at specified timepoints.
Timepoint [7] 320989 0
Baseline, 6 and 12 months
Secondary outcome [8] 320990 0
Composite outcome of endothelial function. We will quantify soluble VCAM and ADMA from venous blood samples collected at specified timepoints.
Timepoint [8] 320990 0
Baseline, 6 and 12 months
Secondary outcome [9] 320991 0
Cardiovascular Risk Factors: Composite outcome of blood pressure, blood lipids (triglycerides, LDL-C, HDL-C) and glycated haemoglobin (HbA1c) will be quantified by venous sampling. Body mass and height will be measured to determine body mass index. Waist circumference will be measured according to standardised methods.
Timepoint [9] 320991 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
Patients with AF.
Patients with at least moderate obstructive sleep apnea defined AHI of 15 or greater.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant pulmonary disease
Life expectancy < 24 months
Severely elevated Epworth Sleepiness Scores that may pose driving risk
Involvement in another trial that will compromise this trial
Reversible cause of AF

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients with AF are screened for OSA. Patients with at least moderate OSA (AHI >=15) and who meet the above inclusion criteria will be offered entry into the trial. Consenting patients will be then randomised using a computerised randomisation tool. Upon enrolment and randomisation a unique numerical identifier code will be allocated to each patient for entry into the database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization between 0 (control) and 1 (active) using an electronic random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Follow up for 12 months following enrolment
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5301 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 5302 0
Melbourne Private Hospital - Parkville
Recruitment postcode(s) [1] 12768 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 12769 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 292927 0
Hospital
Name [1] 292927 0
Royal Melbourne Hospital (teaching Hopsital of The University of Melbourne) Department of Electrophysiology
Country [1] 292927 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan Street
Royal Melbourne Hospital
Parkville, 3050
Vic
Country
Australia
Secondary sponsor category [1] 291684 0
University
Name [1] 291684 0
The University of Melbourne
Address [1] 291684 0
Parkville Vic
3010
Country [1] 291684 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294433 0
Melbourne Health, Human Research Ethics Committee
Ethics committee address [1] 294433 0
Ethics committee country [1] 294433 0
Australia
Date submitted for ethics approval [1] 294433 0
27/07/2015
Approval date [1] 294433 0
19/08/2015
Ethics approval number [1] 294433 0
HREC/15/MH/356

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63686 0
Prof Jonathan Kalman
Address 63686 0
Suite 1, Melbourne Heart Centre
Royal Melbourne Hospital
Royal Parade
Parkville Vic, 3050
Australia
Country 63686 0
Australia
Phone 63686 0
+61 3 9349 5400
Fax 63686 0
Email 63686 0
[email protected]
Contact person for public queries
Name 63687 0
Chrishan Nalliah
Address 63687 0
Royal Melbourne Hospital
300 Grattan Street
Parkville Vic, 3050
Country 63687 0
Australia
Phone 63687 0
+61 415 316 498
Fax 63687 0
Email 63687 0
[email protected]
Contact person for scientific queries
Name 63688 0
Chrishan Nalliah
Address 63688 0
Royal Melbourne Hospital
300 Grattan Street
Parkville Vic, 3050
Country 63688 0
Australia
Phone 63688 0
+61 415 316 498
Fax 63688 0
Email 63688 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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