The Institute for Biomedical Research in Southern Catalonia (IRB CatSud) has launched the PERIVERSION clinical trial (Multicenter, randomized clinical trial to evaluate the cardioverter capacity of amiodarone pre-electrical cardioversion in persistent atrial fibrillation), the first study with drugs in which the institute plays the role of promoter. It is an academic, independent and low-level intervention trial that aims to evaluate the efficacy of amiodarone to reverse persistent atrial fibrillation before performing electrical cardioversion.
“Although this drug is the most widely used antiarrhythmic in Europe, there is still no solid clinical evidence on its usefulness or the optimal administration regimen in this indication,” says Josep M. Alegret, who leads the trial and is responsible for the Cardiovascular Research Group at IRB CatSud and clinical head of the Cardiology Service at the Sant Joan University Hospital in Reus.
Atrial fibrillation is the most common cardiac arrhythmia and affects approximately 4% to 5% of the population over 40 years of age, a figure that increases to 18% in people over 80 years of age. Among the main risk factors associated with this pathology are aging, high blood pressure and certain heart diseases, such as heart failure or valvular diseases.
This alteration in heart rhythm can cause palpitations, heart failure and a significant increase in the risk of stroke. For this reason, improving the available therapeutic strategies has a direct impact on the quality of life and prognosis of patients.
The study also includes the participation of different reference hospital centers, including the Hospital de Sant Pau, the Germans Trias i Pujol University Hospital, the Hospital Clínico de Santiago and the Sant Joan University Hospital in Reus. Soon, the Joan XXIII University Hospital and other centers in the State will also be included.
The trial will compare two different amiodarone administration regimens: one initiated five days before electrical cardioversion and another initiated one month before. In this way, the researchers want to determine whether the treatment is capable of not only preventing new recurrences of the arrhythmia, but also reversing it before the scheduled electrical intervention.
According to the research team, the implementation of this project represents a significant organizational challenge for IRB CatSud, as it requires a specific infrastructure and qualified personnel to manage the regulatory processes associated with clinical trials with drugs. At the same time, it consolidates the institute’s leadership and execution capacity in the field of clinical research.
The project has received funding from the Catalan Society of Cardiology and the Spanish Society of Cardiology, two entities that have committed to generating new scientific evidence on a disease that affects hundreds of thousands of people and to optimizing the treatment of one of the most prevalent arrhythmias in the population.
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