Rate control therapy evaluation in atrial fibrillation

INTERVENTION: Participants are be randomised to one of two groups in a 1:1 ratio by a computer generated and stratified minimisation algorithm: Group 1: Participants receive Digoxin 62.5 – 250 micrograms once daily uptitrated according to response and symptoms. Group 2: Participants receive Bisoprolol 1.25 – 15 mg once daily uptitrated according to response and symptoms. Patients in both groups will remain on treatment for 12 months as part of the trial. The trial is testing the initial randomisation to either a digoxin or beta‐blocker strategy. In both groups, additional therapy will likely be needed over the course of the trial. Follow‐up takes place at 6 and 12 months, and involves quality of life measurement, heart ultrasound (echocardiography), blood tests and assessment of function (questionnaires and a walking test). Most patients will continue their treatment after the trial, according to their needs. CONDITION: Specialty: Cardiovascular disease, Primary sub‐specialty: Other; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease ; Circulatory System ; Atrial fibrillation PRIMARY OUTCOME: Patient‐reported quality of life is measured using the SF‐36 physical component summary score at baseline and 6 months SECONDARY OUTCOME: 1. Patient‐reported quality of life is measured using SF‐36 global and domain‐specific scores, EQ‐5D‐5L summary index and visual analogue scale and AFEQT overall score at baseline, 6 and 12 months; 2. Cardiac function is assessed by measuring echocardiographic left ventricular ejection fraction and diastolic function (E/e’ and composite of diastolic indices) at baseline and 12 months; 3. Six‐minute walking distance is measured at baseline, 6 and 12 months; 4. European Heart Rhythm Association (EHRA) functional class information is checked at baseline, 6 and 12 months; 5. B‐type natriuretic peptide (BNP) levels and other biomarkers of treatment response are measured using blood testing at baseline, 6 and 12 months; 6. Heart rate control is measured using 24‐hour ambulatory ECG at approximately 3 months INCLUSION CRITERIA: 1. Adult patients aged 60 years or older 2. Permanent AF, characterised (at time of randomisation) as a physician decision for rate‐control with no plans for cardioversion, anti‐arrhythmic medication, or ablation therapy 3. Symptoms of breathlessness (New York Heart Association Class II or more) 4. Able to provide written informed consent