Abstract
BackgroundAtrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited.ObjectiveThe aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial.MethodsA total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points.ResultsResults will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients.ConclusionsThis study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region.Trial RegistrationClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX)Registered Report IdentifierRR1-10.2196/8523
Highlights
BackgroundAtrial fibrillation (AF) is the most common sustained cardiac rhythm disorder, and recent projections in Europe estimate that from 2010 to 2060, the number of adults aged 55 years and older with AF in the European Union will more than double [1]
Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points
Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines
Summary
BackgroundAtrial fibrillation (AF) is the most common sustained cardiac rhythm disorder, and recent projections in Europe estimate that from 2010 to 2060, the number of adults aged 55 years and older with AF in the European Union will more than double [1]. With the aging population and associated prevalence of other cardiovascular diseases, the burden of AF is projected to increase. Given the increasing prevalence and AF’s association with significant morbidities and mortality, this increase would have major public health implications. A significant change in the epidemiologic and etiologic patterns of cardiovascular diseases has been seen in North Africa with a decrease in rheumatic heart disease and increase in hypertensive and ischemic heart disease [2,3]. Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited
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