Atrial Fibrillation Clinical Trial
Official title:
Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE)
Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of
the western population. It may cause symptoms such as irregular heartbeats, shortness of
breath, and fatigue. It may also be asymptomatic (ie "silent atrial fibrillation). In some
cases, atrial fibrillation is permanent whereas in others it is sporadic. Regardless of
symptoms, there is an increased risk of stroke in some patients with this condition. Novel
technologies are being developed to increase detection of silent atrial fibrillation, in
order to find patients who might benefit from treatment with oral anticoagulants
(blood-thinning medications) in order to reduce the risk of stroke. One of these technologies
is thumb-ECG, a simple way for a patient to have his or her heart rhythm reliably analyzed at
home.
Hyperthyroidism (sometimes referred to as "toxic goiter") is defined as an excessive
production of thyroid hormone. It is known that hyperthyroidism may cause atrial fibrillation
in about 8% of cases.
Objective: To provide thumb-ECG-monitors to hyperthyroid patients before and after treating
their hormonal disturbance, in order to find episodes of silent atrial fibrillation.
Design: Prospective observational study.
Hypotheses:
- Primary hypothesis: Silent atrial fibrillation is at least as common as overt atrial
fibrillation in hyperthyroid patients.
- Secondary hypothesis nr 1: Atrial fibrillation continues to be more prevalent compared
to the normal population even after hyperthyroidism is treated.
- Secondary hypothesis nr 2: The majority of patients with hyperthyroidism and atrial
fibrillation are at increased risk of stroke and should be considered for treatment with
oral anticoagulants.
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