Atrial fibrillation and sudden cardiac death assessments, as well as blood analyses, will
be conducted on the entire VITAL Study population, and ECG analyses will be limited to
the Clinical and Translational Science Center (CTSC) sub-cohort of 1,054 VITAL
participants who live near the Boston area and agree to participate in a series of
ancillary studies in addition to the main trial.
Investigators will ascertain atrial fibrillation events utilizing self-report of
physician diagnoses of atrial fibrillation received on annual questionnaires from study
participants supplemented by outpatient and hospital visits for AF identified through
Centers for Medicare and Medicaid Services (CMS) data linkage. Investigators will also
ascertain additional information regarding atrial fibrillation diagnosis from
supplementary questionnaires, and seek consent to review all inpatient and outpatient
hospital records pertaining to atrial fibrillation diagnosis and evaluation. Atrial
fibrillation events will be confirmed by an endpoint committee composed of cardiologists,
which will also make a determination on atrial fibrillation subtype and pattern.
Questionnaires that inquire about recurrent atrial fibrillation events, pattern of AF,
latest medical record evaluation and treatments for AF will be sent to participants with
confirmed atrial fibrillation. Medical records will be requested and reviewed an endpoint
committee to determine atrial fibrillation subtype and progression. An intention-to-treat
analysis examining the 5-year treatment effects of omega-3 fatty acids and vitamin D on
incident atrial fibrillation, as well as subtypes at the time of diagnosis will be
performed to address the primary aims. We will repeat these analyses at the end of
extended follow-up to assess cumulative and post-treatment effects of omega-3 fatty acids
and vitamin D and AF subtypes two years after diagnosis.
Electrocardiograms will be obtained at baseline and again after two years of treatment
and follow-up among a sub-cohort of 1,054 patients being enrolled in VITAL at the CTSC.
Investigators will utilize these ECG data to evaluate whether treatment with omega-3
fatty acids and vitamin D3 have significant effects on ECG measures. The ECGs will also
be utilized to estimate the prevalence of asymptomatic persistent atrial fibrillation in
our population not detected by our atrial fibrillation surveillance methods.
Investigators will examine baseline blood samples for participants with confirmed atrial
fibrillation for the purpose of exploring whether the effect of vitamin D3 or fish oil
supplementation on atrial fibrillation risk varies by the baseline blood levels of these
nutrients.
Investigators will also seek additional information necessary to classify deaths as
sudden or arrhythmic in origin, and cardiac deaths will be reviewed by an endpoint
committee of cardiologists. Once these results have been compiled investigators will
explore whether omega-3 fatty acids and/or vitamin D might have an effect on sudden
and/or arrhythmic cardiac death.
