ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12606000164594

Ethics application status

Approved

Date submitted

13/09/2005

Date registered

9/05/2006

Date last updated

24/09/2024

Date data sharing statement initially provided

24/09/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

Clinical & Neurohormonal Prediction Of Outcome In Atrial Fibrillation

Scientific title

A study to assess whether clinical and neurohormal markers can predict the outcome of biphasic versus monsophasic cardioversion for atrial fibrillation.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

CHOP-CAF

Linked study record

Health condition

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

Atrial Fibrillation

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will also be randomly assigned to biphasic defibrillation as a single cardioversion procedure which takes about 3-5 minutes.

Intervention code [1]

None

Comparator / control treatment

Participants will also be randomly assigned to monophasic defibrillation as a single cardioversion procedure which takes about 3-5 minutes.

Control group

Dose comparison

Outcomes

Primary outcome [1]

The main aim of this study is to determine whether the hormones atrial natriuretic peptide (ANP) can improve our ability to predict successful cardioversion in atrial fibrillation.

Timepoint [1]

Measured prior to cardioversion and again at 6 weeks and 12 months afterwards.

Primary outcome [2]

The main aim of this study is to determine whether the hormones brain natriuretic peptide (BNP) can improve our ability to predict successful cardioversion in atrial fibrillation.

Timepoint [2]

Measured prior to cardioversion and again at 6 weeks and 12 months afterwards.

Secondary outcome [1]

In this study we will try to develop a tool that could help in predicting the short and long term outcome post DC cardioversion for the patients with atrial fibrillation. The tool will incorporate the data collected from the different blood tests and imaging results. It will, also, take in consideration the medical background and pharmacological agents commonly used in this condition.
Compare between 2 different types of defibrillators used to perform DC cardioversion (Monophasic & Biphasic). The aim will be to identify which type of defibrillator has better outcome and less complications.
Record the possible complications associated with atrial fibrillation and its treatment over the follow up period.

Timepoint [1]

Eligibility

Key inclusion criteria

Atrial fibrillation or flutter on the waiting list for elective DC cardioversion who are welling to participate and capable of attending follow up appointments.

Minimum age

18 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Any patient who is unable or not welling to consent to be enrolled, and patients who can not attend the follow up appointment.

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)

Central randomisation by an on-site computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

8/01/2003

Actual

8/01/2003

Date of last participant enrolment

Anticipated

Actual

23/10/2009

Date of last data collection

Anticipated

Actual

1/07/2024

Sample size

Target

200

Accrual to date

Final

280

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Christchurch Cardioendocrine Research Trust

Address [1]

Country [1]

New Zealand

Primary sponsor type

University

Name

Christchurch Cardioendocrine Research Group

Address

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Christchurch

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

CTR/03/07/118

Summary

Brief summary

All patients on the waiting list for elective DC cardiovesion will be offered the chance to participate In this study. If they agree, we will record the results of the different laboratory and imaging tests that they had prior to presenting to the preadmission clinic, as well as each individual medical background.
Each patient will have 4 extra blood tests to measure the hormones produced by the heart and other parts of the body in response to their heart condition. The first 2 tests will be on the day they present for the electric shock treatment (DC cardiovesion). The 3rd when having the 6 weeks routine follow up, and the last one will be when having the 6 months follow up. Each patient will, also, have an additional ultrasound examination of the heart 4-8 months following having the DC cardioversion.
Each patient will be followed for a minimum of 1 year (the 2 other follow ups at 6&12 months post DC cardioversion). During this time we will monitor the heart rhythm, the rate of possible complications with this condition and analyse the data trying to identify the patients who may benefit from this treatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Professor Richard Troughton

Address

Department of Medicine Christchurch School of Medicine & Health Sciences PO Box 4345 Christchurch

Country

New Zealand

Phone

+6433640640

Fax

Richard Troughton@cdhb.health.nz

Contact person for public queries

Name

Lorraine Skelton

Address

Department of Medicine
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch

Country

New Zealand

Phone

+64 3 3641063

Fax

+64 3 3641115

lorraine.skelton@cdhb.govt.nz

Contact person for scientific queries

Name

Dr Amjad Hamid

Address

Christchurch Hospital
PO Box 4710
Christchurch

Country

New Zealand

Phone

+64 3 364 0640

Fax

+64 3 3641115

amjad.hamid@cdhb.govt.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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