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 to request a patient information sheet
Condition
Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Arrhythmia
Intervention
Isoprenaline
Intervention type
Drug
Phase
Not Applicable
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
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