Until now, scientific research about treatment for the most common type of heart arrhythmia, atrial fibrillation (AFib), has primarily focused on patients with already established cases of the condition. CHANGE AFib, a new pragmatic clinical trial, will determine whether early treatment with the antiarrhythmic drug dronedarone improves cardiovascular and long-term outcomes in patients presenting to the hospital with first-detected AFib.

The trial represents a collaboration between the American Heart Association, a global force for healthier lives for all, and the Duke Clinical Research Institute (DCRI), the world’s largest academic clinical research organisation, with support from Sanofi US.

AFib is an irregular heartbeat (arrhythmia) that results from the top chamber of the heart—the left atrium—developing a quivering electrical pattern. AFib can lead to blood clots, stroke, heart failure and other heart-related complications if left untreated.

Patients with AFib are hospitalised twice as often as patients without AFib and are three times more likely to have multiple admissions. According to a report published in the American Heart Association journal Circulation, up to 84% of strokes in AFib patients could be prevented with effective treatment, but about half of patients do not receive proper therapy.

”Although several clinical trials have addressed the optimal treatment strategy for patients with symptomatic and recurrent atrial fibrillation, we do not yet have evidence on the best early treatment plan for those who have just been diagnosed with first-detected cases,” said Jonathan Piccini, MD, MHS, American Heart Association volunteer, cardiac electrophysiologist and associate professor of medicine at Duke University / DCRI and principal investigator for the trial.

“CHANGE AFib seeks to fill this gap in evidence and determine whether we can better deliver early treatment to help improve long-term outcomes in patients with first-detected atrial fibrillation.”

The CHANGE AFib trial will conclude in 2024, which also happens to be the American Heart Association’s centennial year, and will be conducted using patient data from hospitals participating in the American Heart Association’s nationwide Get With The Guidelines® – AFib registry.

Get With The Guidelines® is the American Heart Association/American Stroke Association’s hospital-based quality improvement program that provides hospitals with the latest research-based guidelines. Developed with the goal of saving lives and accelerating recovery, Get With The Guidelines has impacted the lives of more than 10 million patients since 2001.

Data is collected through the registries and can then be used effectively and efficiently for research such as the CHANGE AFib trial. Patient outcomes improve when medical professionals follow the most up-to-date evidence-based treatment guidelines.

“It’s estimated that by 2030, atrial fibrillation will affect 12.1 million people in the United States, more than double the number in 2010,” said Mariell Jessup, MD, FAHA and chief staff science and medical officer at the American Heart Association.

“People living with AFib are nearly five times more likely to have a stroke. Establishing treatment options for newly diagnosed patients is an integral part of a care plan that helps them live longer, healthier lives.”

People of all ages can develop AFib and the risk increases with age. While the cause is unknown in certain cases, AFib can also result from damage to the heart's electrical system from other risk factors such as longstanding, uncontrolled high blood pressure, diabetes, obesity, smoking and heart disease. People living with AFib often have other health conditions and don’t realise their symptoms are a result of their AFib. Some of these symptoms could potentially be resolved with rhythm therapy.

“We are honored to support the American Heart Association and the Duke Clinical Research Institute on this important initiative that could potentially shift the paradigm of how we take care of people living with atrial fibrillation,” said Rogelio Braceras, MD, North America head of medical for General Medicines, Sanofi.

“CHANGE AFib represents a unique opportunity to investigate the role of dronedarone when used early in the course of the condition.”