Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000857606
Ethics application status
Approved
Date submitted
10/07/2014
Date registered
8/08/2014
Date last updated
15/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing exercise capacity, inflammation and endothelial function following cardioversion between asymptomatic and symptomatic patients with atrial fibrillation
Scientific title
Changes in exercise capacity, inflammation and endothelial function following cardioversion in asymptomatic versus symptomatic persistent atrial fibrillation
Secondary ID [1] 284961 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 292454 0
Condition category
Condition code
Cardiovascular 292770 292770 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Direct electrical cardioversion. The cardioversion will be performed under sedation. Remote patches will be attached in Anterior-posterior or anterior-lateral position and 200 Joule synchronized shock will be delivered. A maximum of three shocks will be delivered to restore sinus rhythm. Cardioversion will be performed on a single occasion, lasting approximately 30 minutes.
Intervention code [1] 289790 0
Treatment: Other
Intervention code [2] 289867 0
Treatment: Devices
Comparator / control treatment
Symptomatic AF patients
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292620 0
Exercise capacity, defined using peak oxygen consumption
Timepoint [1] 292620 0
12 weeks post cardioversion
Secondary outcome [1] 309348 0
Endothelial Function, assessed by reactive hyperemia and serum assay.
Timepoint [1] 309348 0
12 weeks
Secondary outcome [2] 309349 0
Inflammation assessed by serum assay
Timepoint [2] 309349 0
12 weeks

Eligibility
Key inclusion criteria
Persistent AF, defined as an episode of AF lasting longer than 7 days or lasts <7 days and requires direct cardioversion.
Rate controlled during AF with resting ventricular rate less than 110bpm.
Able and willing to provide written informed consent to participate.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients contraindicated for exercise testing according to American Heart Association guidelines.
Paroxysmal (AF duration <7 days) or Permanent AF (AF duration >1 year).
Decompensated heart failure
Unstable angina.
Hemodynamic instability defined as systolic blood pressure less than 90mmHg.
Previous AF ablation
Pregnancy or suspected pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
To examine the predictors of change in exercise capacity following cardioversion, we will use a multivariable mixed-effects model with the change in exercise capacity (VO2max) as the dependent variable. Analysis of variance (ANOVA) for repeated measures will be used to assess the change of haematological, morphological and QoL parameters following cardioversion. A P value <0.05 will be considered significant.

Using the mean VO2max value of 20.7+/- 6.3 ml/kg/min reported in persistent AF (Fiala et al., 2013) and a 50% attrition rate accounting for those not remaining in sinus rhythm, a recruitment target of 35 patients per group will give 80% power to detect a 3.5 ml/kg/min change in VO2max.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2714 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 289582 0
University
Name [1] 289582 0
University of Adelaide
Country [1] 289582 0
Australia
Primary sponsor type
University
Name
Centre for Heart Rhythm Disorders
Address
Centre for Heart Rhythm Disorders
Level 5
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 288267 0
University
Name [1] 288267 0
School of Medical Sciences
Address [1] 288267 0
School of Medical Sciences
Level 4 Medical School South
Frome Road
Adelaide
SA 5005
Country [1] 288267 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291319 0
Royal Adelaide Hospital
Ethics committee address [1] 291319 0
Level 3, IMVS Building
Royal Adelaide Hospital
Adelaide
SA 5000
Ethics committee country [1] 291319 0
Australia
Date submitted for ethics approval [1] 291319 0
12/06/2014
Approval date [1] 291319 0
07/07/2014
Ethics approval number [1] 291319 0
HREC/14/RAH/250

Summary
Brief summary
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1-2% of the population. Many patients remain asymptomatic, likely leading to an underestimation of the true prevalence of AF. Of particular importance is the similar risk of stroke and adverse health outcomes in the asymptomatic cohort. Catheter ablation has emerged as an effective treatment for symptomatic AF. However, the risk to benefit ratio of an ablation procedure in asymptomatic AF is less established.

(i) Examine whether the restoration of sinus rhythm by cardioversion in asymptomatic patients improves exercise capacity to a similar degree as patients with symptomatic AF.
(ii) Compare baseline and post-exercise parameters of the prothrombotic state between symptomatic and asymptomatic patients both before after cardioversion

(1) We hypothesize that exercise capacity will be similarly impaired in symptomatic and asymptomatic patients and improve following restoration of sinus rhythm following cardioversion.
(2) We further hypothesise that:
a. acute exercise will elevate the prothrombotic state in both symptomatic and asymptomatic patients and;
b. inflammation and endothelial dysfunction will be observed in both patient cohorts and similarly improved following the return of sinus rhythm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49870 0
Prof Prashanthan Sanders
Address 49870 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Adelaide
SA 5000
Country 49870 0
Australia
Phone 49870 0
61882222272
Fax 49870 0
Email 49870 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 49871 0
Adrian Elliott
Address 49871 0
School of Medical Sciences, University of Adelaide
Med School South, Frome Road
Adelaide
SA 5005
Country 49871 0
Australia
Phone 49871 0
61883133194
Fax 49871 0
Email 49871 0
adrian.elliott@adelaide.edu.au
Contact person for scientific queries
Name 49872 0
Rajiv Mahajan
Address 49872 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Adelaide
SA 5000
Country 49872 0
Australia
Phone 49872 0
61883133194
Fax 49872 0
Email 49872 0
rajiv.mahajan@adelaide.edu.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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