The purpose of this study to investigate the effects of colchicine on atrial fibrillation recurrence and vascular and cardiac function in patients with atrial fibrillation.
The study is an investigator-initiated, prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effects of colchicine in patients with atrial fibrillation (AF). The study population will consist of approximately 500 patients aged 18 years and above with a diagnosis of paroxysmic or persistent AF with a successful outcome of cardioversion. Patients will be randomized to either low-dose colchicine treatment (0,5 mg once daily) or placebo. Treatment will continue for 12 months. Patients will be assessed by measurement of time to first admission with AF (Electro Cardio Gram (ECG) confirmed), echocardiography, cardiac Magnetic Resonance Imaging (MRI), and blood samples at baseline and after 6 + 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
Colchicine 0.5 mg once daily
Placebo once daily
Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)
Hellerup, Denmark
RECRUITINGBetween-group difference in change in time to first AF admission measured in days
Time frame: 12 months
Between-group difference in change in accumulated number of readmissions for symptomatic AF
Time frame: 12 months
Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography
Time frame: 12 months
Between-group difference in change in Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) score
Score of 0 being the worst outcome and score of 100 being the best outcome
Time frame: 12 months
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