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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 0.5 mg once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in change in time to first AF admission measured in days | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in change in accumulated number of readmissions for symptomatic AF | 12 months | |
| Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in change in plasma concentration of high sensitivity C-Reactive Protein (hs-CRP) | 12 months | |
| Between-group difference in change in plasma concentration of high sensitivity Troponin I (hs-TnI) | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Femerling Langhoff, M.D. | Contact | +4522552317 | adam.femerling.langhoff@regionh.dk | |
| Tor Biering-Sørensen, MD, PhD, MPH | Contact | +4528933590 | tor.biering-soerensen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Adam Femerling Langhoff, M.D. | Herlev and Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) | Recruiting | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Drug |
Placebo once daily |
|
| 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 | 12 months |
| Between-group difference in change in Left Ventricle (LV) septal wall thickness assessed by echocardiography | 12 months |
| Between-group difference in change in LV mass index assessed by echocardiography | 12 months |
| Between-group difference in change in LV posterior wall thickness assessed by echocardiography | 12 months |
| Between-group difference in change in Left Ventricle Ejection Fraction (LVEF) assessed by echocardiography | 12 months |
| Between-group difference in change in E/A ratio assessed by echocardiography | 12 months |
| Between-group difference in change in e' assessed by echocardiography | 12 months |
| Between-group difference in change in E/e' ratio assessed by echocardiography | 12 months |
| Between-group difference in change in Global Longitudinal Strain (GLS) assessed by echocardiography | 12 months |
| Between-group difference in change in aortic distensibility assessed by echocardiography | 12 months |
| Between-group difference in change in aortic strain assessed by echocardiography | 12 months |
| Between-group difference in change in LV septal wall thickness assessed by cardiac MRI | 12 months |
| Between-group difference in change in LV posterior wall thickness assessed by cardiac MRI | 12 months |
| Between-group difference in change in LVEF assessed by cardiac MRI | 12 months |
| Between-group difference in change in myocardial fibrosis assessed by cardiac MRI | 12 months |
| Between-group difference in change in myocardial inflammation assessed by cardiac MRI | 12 months |
| Between-group difference in change in plasma concentration of Tumor Necrosis Factor alpha (TNF-α) | 12 months |
| Between-group difference in change in plasma concentration of pro Brain Natriuretic Peptide (pro-BNP) | 12 months |
| Between-group difference in change in accumulated number of cardiovascular-related hospital visits | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |