Secondary Prevention of Atrial Fibrilation

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation, Risk Factors, Risk Reduction Behavior

In brief

Atrial fibrillation (AF) is the most common arrhythmia affecting over 3 million Americans and about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for adults over age 40 years. AF is associated with a major medical and socioeconomic burden including high cost, increased risk of stroke, heart failure, dementia, myocardial infarction, and death. Numerous studies have demonstrated that modifiable risk factors including hypertension, obesity, sleep apnea, diabetes, and sedentary lifestyle predict the development of AF. Recent studies have reported that secondary prevention interventions through aggressive risk factor modification can reduce the burden of AF. Structured, physician and nursing-led interdisciplinary AF programs have been shown to improve patient adherence to guideline recommendations and improve long term prognosis. Previous data, however, are derived mainly from white European and Australian cohorts and it is unclear whether such interventions can be effectively implemented in a racially diverse, safety net hospital in the U.S. This study is a randomized hybrid implementation-effectiveness study designed to investigate feasibility and effectiveness of an evidence-based innovative AF program, focusing on risk factor modification and AF education in a racially mixed population receiving care in a safety net hospital.

Key facts

Study ID

NCT03259893

Run by

Boston Medical Center

People needed

3

Starts

2018-02-01

Expected to finish

2020-05-11

Last updated by the study team

2021-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Diagnosis of paroxysmal AF (based on 12-lead electrocardiogram or event monitor showing AF).
• Body mass index of greater than 27 kg/m2
• Eligibility to participate in cardiac rehabilitation with negative exercise stress test within 6 months.

You may not qualify if…

• Permanent AF.
• Undergone catheter ablation of AF in past 6 months.
• Class I or Class III anti-arrhythmic drugs at the time of enrollment
• Unable to participate in cardiac rehabilitation.
• Prognosis of less than 1-year.
• Do not own a smart phone.
• Unable to operate (transmit data) their smart phone.
• Are not fluent in English or Spanish.
• Unable to read in English or Spanish.
• Not able to provide informed consent.
• Women who are pregnant.
• Prisoners.

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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