Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE)

Karolinska Institute

Status: Terminated

Conditions: Atrial Fibrillation; Hyperthyroidism

Study type: Observational

Funder types: Other

Identifiers

NCT01945229

3/9 B

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is deemed suitable for treatment with radioiodine or antithyroid drugs
• Patient has a thyreotropin (TSH) value below 0,1 mIU/L, measured less than 2 weeks before inclusion
• Patient has a CHADS-VASc-score of 1 point or higher (excluding if 1 point is for female sex only)
• Patient gives written consent to participate in study

Exclusion criteria

• Patient has a previously known diagnosis of atrial fibrillation

Trial design

110 participants in 1 patient group

Hyperthyroid patients

Description:

Patients with hyperthyroidism admitted for treatment with radioiodine or antithyroid drugs