Isoprenaline infusion as a method of induction of atrial fibrillation
| ISRCTN | ISRCTN17309312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17309312 |
| EudraCT/CTIS number | 2014-002290-11 |
| Secondary identifying numbers | 18091 |
- Submission date
- 08/01/2015
- Registration date
- 12/01/2015
- Last edited
- 16/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Plain English summary under review
Contact information
Dr Study Contact
Scientific
Scientific
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
| Phone | +44 (0)300 019 8500 |
|---|---|
| researchsponsorship@uhd.nhs.uk |
Study information
| Study design | Randomised; Interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | IsoAF study |
| Study objectives | 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(s) | 14/SC/1171 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Arrhythmia |
| Intervention | Isoprenaline |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Isoprenaline |
| Primary outcome measure | Presence or absence of atrial fibrillation |
| Secondary outcome measures | N/A |
| Overall study start date | 05/01/2015 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 235; UK Sample Size: 235 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/01/2015 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Sponsor information
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
England
United Kingdom
"ROR" |
https://ror.org/03xqffv86 |
|---|
Funders
Funder type
Government
Bournemouth Cardiac Research Fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 4.0 | 09/09/2014 | 28/04/2023 | No | No |
| Basic results | 16/02/2024 | No | No | ||
| Other files | Statement from sponsor regarding data quality | 16/02/2024 | No | No |
Additional files
- ISRCTN17309312_Protocol_V4.0_09Sept2014.pdf
- ISRCTN17309312 IsoAF statement FINAL.pdf
- Statement from sponsor regarding data quality
- ISRCTN17309312ct_result_2014-002290-11.pdf
Editorial Notes
16/02/2024: The following changes were made to the trial record:
1. A file containing a statement from the sponsor regarding data quality was uploaded as an additional file.
2. A basic results file from EudraCT was uploaded as an additional file.
28/04/2023: The following changes have been made to the study record:
1. Uploaded protocol (not peer reviewed).
2. The scientific contact has been changed.
19/01/2018: No publications found, verifying study status with principal investigator.
