New onset atrial fibrillation (NOAF) Circulatory System
Conditions
Interventions
Patients will be randomised following confirmation of eligibility by a medically qualified doctor. They will be randomised to receive either amiodarone or beta-blockade. The choice of dose (and in the
dosing should be according to local practice. Patients will be treated with the allocated intervention until sinus rhythm has been maintained for 24 hours. Clinicians should then consider stopping the
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 15/06/2026: 1. Adult Patients (age =16 years) 2. Monitored in an area of higher care with the ability to deliver the interventions 3. Onset of NOAF or a new episode of AF during the acute illness (A&E, deterioration on ward, after surgery) where there is a clinical indication to treat with amiodarone or beta blockers as determined by the attending clinician/ACCP or equivalent. 4. Usual electrolyte management with potassium and magnesium has taken place according to site practice _____ Previous key inclusion criteria: 1. Patients in an adult ICU (age =16 years) 2. Onset of NOAF during the acute illness (A&E, deterioration on ward, after surgery) having previously been in sinus rhythm and not known to previously have had AF. 3. A minimum duration of AF of at least 30 minutes 4. Usual electrolyte management with potassium and magnesium according to site practice 5. A clinical indication to treat NOAF as determined by the attending clinician
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 15/06/2026: 1. Treatment with anticoagulants or antiarrhythmics for the treatment of AF before the current hospital admission *anticoagulants or antiarrhythmics used for any other purpose can be included 2. Current concomitant medication that are contraindicated with the intervention or comparator medications (for example ciclosporin, itaconazole, letermovir) 3. Serum potassium of less than 4 mmol L-1 (measured either on point-of-care testing or laboratory) 4. Patients having undergone cardiac surgery during the current hospital admission, defined as any surgery including lung resections, stent procedures such as percutaneous coronary interventions or other angioplasty procedures done on the heart muscle, valves or thoracic arteries including the thoracic part of the aorta 5. Thyrotoxicosis 6. Withdrawal of life support therapy within 24 hours 7. Any other known contraindication or known sensitivity to beta-blockers or amiodarone 8. Known pregnancy or patients currently known to be breast-feeding _____ Previous key exclusion criteria: 1. Patients in receipt of amiodarone or a beta-blocker in the previous 24 hours 2. Patients receiving current concomitant medication with treatments that are contraindicated with the intervention/comparator medications 3. Patients with a serum potassium of <4 mmol L-1 4. Patients with a serum magnesium of <1.0 mmol L-1 5. Patients having undergone cardiac surgery during the current hospital admission, defined as any surgery including stent procedures such as percutaneous coronary interventions or other angioplasty procedures done on the heart muscle, valves or thoracic arteries including the thoracic part of the aorta 6. Patients with Thyrotoxicosis 7. Patients where there is a plan for withdrawal of life support therapy within 24 hours 8. Patients who have had other thoracic surgery that ingresses the thorax 9. Patients with any other known contraindication or known sensitivity to beta-blockers or amiodarone 10. Patients with a known pregnancy or patients currently known to be breastfeeding 11. Patients with any known previous documented history of AF, whether permanent, persistent or paroxysmal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day mortality measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ICU and hospital mortality measured up to day 90 using patient's medical notes 2. Rates of cardiovascular events including stroke, myocardial infarction or thromboembolism up to 90 days using patient's medical notes 3. Rate of established AF by the end of ICU stay/death/day 90 by using patient's medical notes 4. Number of episodes of bradycardia up to day 90 by using patient's medical notes 5. Number of bradycardia and bradycardic arrhythmias with haemodynamic compromise requiring intervention measured up to day 90 by using patient's medical notes 6. Number of significant hypotension episodes requiring intervention up to day 90 by using the patient's medical notes 7. Heart block measured up to day 90 by using patient's medical notes 8. Arrhythmia with haemodynamic compromise requiring intervention including DC cardioversion up to day 90 by using patient's medical notes 9. Cost-effectiveness of the interventions measured up to day 90 by using patient's medical notes 10. Healthcare resource use including ICU and hospital length of stay measured up to day 90 by using patient's medical notes | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed