Colchicine After Electrocardioversion for Atrial Fibrillation

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a three-month treatment with low-dose Colchicine can help prevent the return of Atrial Fibrillation (AF) after a procedure called electrocardioversion (ECV). ECV is a treatment that resets the heart's rhythm to normal. The study is open to adults aged 18 and older who have been diagnosed with AF and successfully converted back to a normal heart rhythm after ECV, staying in that rhythm for at least 30 minutes afterward.

To participate, individuals must not have certain health conditions, such as ongoing AF immediately after ECV or serious liver or kidney problems. They also should not be pregnant or breastfeeding and must be able to provide informed consent. Participants will receive low-dose Colchicine for three months and will be monitored to see if it helps keep their heart rhythm stable. This trial is currently recruiting, and it's an important opportunity for those who experience AF to potentially benefit from a new treatment approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>18 years
• • ECG-documented AF prior to ECV
• • Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥30 minutes after ECV
• • Ability to give written informed consent
• Exclusion Criteria:
• • AF persistence after cardioversion or early AF recurrence within 30 minutes after ECV
• • Any other rhythm than AF before cardioversion
• • Pulmonary vein isolation within 3 months prior to ECV or pulmonary vein isolation planned within 3 months after ECV
• • Known intolerance or hypersensitivity to Colchicine
• • Any other absolute indication for Colchicine intake
• • Intake of a strong inhibitor of CYP3A4 or P-Glycoprotein (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
• • Serious gastrointestinal disease (severe gastritis or diarrhea)
• • Clinically overt hepatic disease
• • Severe renal disease (eGFR\< 30ml/min/1.73m2)
• • Clinically significant blood dyscrasia (e.g., myelodysplasia)
• • Significant immunosuppression (e.g. due to transplantation or rheumatic disease)
• • Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
• • Life expectancy \<1 year