Skip to main content
. 2019 Sep 4;2019(9):CD005049. doi: 10.1002/14651858.CD005049.pub5

DIAMOND 2001.

Methods RCT
Double‐blind
Loss to follow‐up reported: yes
Participants Persistent AF (mean duration: NS) in people with heart failure or recent myocardial infarction and reduced LVEF. n = 506
Men: 77%
Age (mean): 72 (range 36–92) years
Structural heart disease: 100%. LAD: NS. LVEF: NS, all < 35%
Interventions Dofetilide 500 µg/day vs placebo
Method of AF cardioversion: spontaneous or pharmacological 63%, electrical 37%
Warfarin discretionary
Outcomes At 12 and 24 months:
Mortality
Proarrhythmia
Heart failure
AF recurrence
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random sequence.
Allocation concealment (selection bias) Low risk Allocation by a central office after inclusion.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind study using matching placebo.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No participant was lost to follow‐up.
Selective reporting (reporting bias) Low risk All outcomes prespecified and all expected outcomes of interest were well reported. Members of an events committee reviewed available data on a blinded basis and classified deaths.
Other bias Unclear risk Substudy from the 2 DIAMOND RCTs which were not stratified by rhythm.