Atrial Fibrillation, Cardiac Arrhythmia
Conditions
Keywords
Electrocardioversion, Colchicine
Brief summary
The purpose of this study is to investigate whether a 3 month treatment course of low-dose Colchicine decreases the recurrence of Atrial fibrillation (AF) after electrocardioversion (ECV) in patients with AF.
Detailed description
Atrial fibrillation is the most common cardiac arrhythmia worldwide and is associated with an increased risk of heart failure, stroke and death. Over the next 40 years the investigators expect another increase in the prevalence of atrial fibrillation with a risk of 1:3 in people over 65 years to develop atrial fibrillation. Electroconversion can occur in patients with atrial fibrillation reestablish sinus rhythm acutely with a controlled electrical shock. Unfortunately it is known however, that there is a short-term recurrence of atrial fibrillation in about 60%. This underlines that our current treatment options are inadequate. There is increasing evidence that inflammation is integral to initiation and maintenance of atrial fibrillation. Therefore, the researchers see inflammation as a possible therapeutic target to reduce the recurrence rate of atrial fibrillation after electroconversion. To test this hypothesis and to help patients, the investigators want to conduct the COLECTRO-AF study.
Interventions
DRUGColchicine
Colchicine 0.5 mg (oral) once daily for 90 days. The chemical name for colchicine is (S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol\[a\]heptalen-7-yl) acetamide. Colchicine consists of pale yellow scales or powder. It is soluble in water, freely soluble in alcohol, and slightly soluble in ether.
DRUGPlacebo
Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.
Sponsors
Swiss Heart Foundation
Fondation Machaon, Switzerland, Genf
Foundation for Cardiovascular Research Basel
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
A randomization list will be provided by the Clinical Trial Unit Basel to an unblinded person at the sponsor's site. The unblinded person will allocate the randomization numbers. Patients and research staff involved in patient recruitment, data management, outcome adjudication and data analyses will fully be blinded
Intervention model description
Prospective, randomized, double-blind, placebo-controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of atrial fibrillation (AF) recurrence | within 6 month after electrocardioversion | The primary outcome of AF recurrence within 6 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of atrial fibrillation (AF) recurrence | within 1 month after electrocardioversion | The secondary outcome of AF recurrence within 1 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG. |
| Time to first redo electrocardioversion | up to 6 month | Time to first redo electrocardioversion |
| Use of antiarrhythmic drugs | within 6 month after electrocardioversion | Assessment of medication intake by study staff Vaughan-Williams classification class 1 and 3 of antiarrhythmic drugs will be documented (1 = sodium channel blockade, 3 = potassium channel blockade) |
| Number of survived participants without an unplanned hospital stay | up to 6 month | Number of survived participants without an unplanned hospital stay |
Countries
Switzerland
Contacts
Primary ContactPhilipp Krisai, PD Dr. med.
Outcome results
None listed