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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]

NONE

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial Fibrillation

Condition category

Condition code

Cardiovascular

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]

Treatment: Other

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Symptomatic AF patients

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Exercise capacity, defined using peak oxygen consumption

Timepoint [1]

12 weeks post cardioversion

Secondary outcome [1]

Endothelial Function, assessed by reactive hyperemia and serum assay.

Timepoint [1]

12 weeks

Secondary outcome [2]

Inflammation assessed by serum assay

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Adelaide

Address [1]

North Terrace
Adelaide
SA 5005

Country [1]

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]

University

Name [1]

School of Medical Sciences

Address [1]

School of Medical Sciences
Level 4 Medical School South
Frome Road
Adelaide
SA 5005

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital

Ethics committee address [1]

Level 3, IMVS Building
Royal Adelaide Hospital
Adelaide
SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/06/2014

Approval date [1]

07/07/2014

Ethics approval number [1]

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

Prof Prashanthan Sanders

Address

Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Adelaide
SA 5000

Country

Australia

Phone

61882222272

Fax

[email protected]

Contact person for public queries

Name

Adrian Elliott

Address

School of Medical Sciences, University of Adelaide
Med School South, Frome Road
Adelaide
SA 5005

Country

Australia

Phone

61883133194

Fax

[email protected]

Contact person for scientific queries

Name

Rajiv Mahajan

Address

Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Adelaide
SA 5000

Country

Australia

Phone

61883133194

Fax

[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

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Documents added automatically

No additional documents have been identified.

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