Condition category
Circulatory System
Date applied
08/01/2015
Date assigned
12/01/2015
Last edited
12/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rob Bowers

ORCID ID

Contact details

Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Additional identifiers

EudraCT number

2014-002290-11

ClinicalTrials.gov number

Protocol/serial number

18091

Study information

Scientific title

Isoprenaline infusion as a method of induction of Atrial Fibrillation: a randomised controlled trial investigating the use of Isoprenaline to induce an episode of atrial fibrillation

Acronym

IsoAF study

Study hypothesis

This study will investigate a use for a well-established drug called isoprenaline. Some doctors use an intravenous infusion of isoprenaline to cause patients to go into an abnormal heart rhythm called atrial fibrillation. This use is part of a procedure to treat that abnormal rhythm. Although it is reasonable to suppose that isoprenaline will have this effect, its ability to induce atrial fibrillation has never been definitively proven. Using a double blinded, placebo controlled design our study will demonstrate the efficacy of induction of atrial fibrillation using an isoprenaline infusion. In addition, the data collected from this trial will demonstrate whether this effect is consistent in the same subject on different occasions and will characterise the ability of isoprenaline to induce atrial fibrillation in different patient groups.

Ethics approval

14/SC/1171

Study design

Randomised; Interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Arrhythmia

Intervention

Isoprenaline

Intervention type

Drug

Phase

Drug names

Isoprenaline

Primary outcome measures

Presence or absence of atrial fibrillation

Secondary outcome measures

N/A

Overall trial start date

05/01/2015

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All Participants in All Groups
1. The participant must be willing to comply with the protocol requirements including travelling to the investigating hospital for the attendances required for the study.
2. Provision of informed consent
3. Participants must be over 18 years of age

Group 1 – Paroxysmal Atrial Fibrillation Group
1. Participants must have a history of arrhythmia with 12 lead ECG or ambulatory ECG monitoring recordings documenting a diagnosis of atrial fibrillation
2. Participants must have a pattern of symptoms and investigation results consistent with a diagnosis of paroxysmal atrial fibrillation

Group 2 – SVT Ablation Group
1. Participants must have a history of arrhythmia with documented regular, narrow complex tachycardia available on either 12 lead ECG or ambulatory ECG monitor recording
2. Participants must be listed to undergo an Electrophysiology study with a view to performing an ablation procedure
3. Participants must go on to have an ablation procedure for either AtrioVentricular Reentrant Tachycardia (AVRT) or AtrioVentricular Nodal Reentrant Tachycardia (AVNRT) with a defined procedural endpoint

Group 3 – Atrial Flutter Ablation Group
1. Participants must have a history of arrhythmia with 12 lead ECG documentation fulfilling prespecified criteria for diagnosis of common type (cavotricuspid isthmus dependent) atrial flutter
2. Participants must be listed to undergo a cavotricuspid isthmus ablation for common type atrial flutter
3. Participants must go on to have only a cavotricuspid isthmus ablation for common type atrial flutter
4. Sustained bidirectional cavotricuspid isthmus block must have been demonstrated as the endpoint for the ablation procedure

Group 4 – Pulmonary Vein Isolation Group
1. Participants must have a history of arrhythmia with 12 lead ECG or ambulatory ECG monitoring recordings documenting a diagnosis of atrial fibrillation
2. Participants must be listed to undergo an ablation procedure for atrial fibrillation with the intent of the attending physician to perform pulmonary vein isolation alone as an ablation strategy
3. Participants must be in sinus rhythm at the time that they enter the Cardiac Electrophysiology Laboratory for their
ablation procedure.
4. Participants must have an ablation procedure for atrial fibrillation and this must have involved only ablation to achieve pulmonary vein isolation
5. Pulmonary vein isolation must have been demonstrated as the endpoint for the ablation procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 235; UK Sample Size: 235

Participant exclusion criteria

All Participants in All Groups
1. Allergy to Isoprenaline
2. Any treatment with Amiodarone in the 3 months prior to ablation procedure
3. Hypertrophic cardiomyopathy
4. Suspected acute myocarditis
5. Uncorrected, severe valvulopathy graded by transthoracic echocardiographic parameters
6. An Acute Coronary Syndrome within the last 6 months
7. Recent (within the last 6 months) or scheduled coronary revascularisation
8. Ongoing angina symptoms without investigations demonstrating the absence of myocardial ischaemia
9. Left ventricular ejection fraction measured at <30%
10. Symptoms of decompensated heart failure syndrome in the last 3 months
11. Severe obstructive lung disease
12. Pregnancy at the time of enrolment or a desire to become pregnant during the study period
13. Reduced life expectancy not associated with cardiovascular disease (less than 1 year)
14. Unable to provide informed consent
Group 1 – Paroxysmal Atrial Fibrillation Group
15. Any past history of episode of persistent atrial fibrillation at the time of enrolment to the study
16. Treatment with any antiarrhythmic agent within six halflives
of that agent from before an administration of the study
drug infusion

Group 2 – SVT Ablation Group
1. Any past history of atrial fibrillation documented on 12 lead ECG or ambulatory ECG monitor
2. Any past history of atrial flutter documented on 12 lead ECG or ambulatory ECG monitor
3. Characterisation of SVT as any arrhythmia other than ANRT or AVNRT
4. Treatment with any antiarrhythmic agent within six halflives
of that agent from the ablation procedure (including intraprocedural
use) with the exception of isoprenaline and adenosine

Group 3 – Atrial Flutter Ablation Group
1. Characterisation of arrhythmia as any arrhythmia other than cavotricuspid
isthmus dependent atrial flutter at the time
of ablation
2. Treatment with any antiarrhythmic agent within six halflives
of that agent from the ablation procedure (including intraprocedural
use) with the exception of isoprenaline and adenosine

Group 4 – Pulmonary Vein Isolation Group
1. Requirement for a more extensive ablation strategy than pulmonary vein isolation alone
2. Intraprocedural treatment with any antiarrhythmic agent with the exception of isoprenaline and adenosine
3. Treatment with any antiarrhythmic agent in the days before the ablation within six halflives of that agent from the ablation procedure

Recruitment start date

05/01/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Sponsor information

Organisation

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Sponsor details

Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Bournemouth Cardiac Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes