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Preliminary analyses of data indicated study should be terminated for futility
TAMBOURINE
Sponsor study identifier
observational
110
1 country
3
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2020
Actual (reported)Study Completion
August 2020
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2013
Actual (reported)September 18, 2013
Actual (reported)February 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 2020
Actual (reported)August 2020
Actual (reported)Prevalence of asymptomatic (silent) atrial fibrillation in hyperthyroid patients
Upon inclusion, each patient will receive a thumb-ECG-monitor to take home. He/she will register his/her heart rhythm twice daily, and can also register at will upon symptoms. This will continue for 2 weeks, after which the monitor is returned.
Upon inclusion and 2 weeks onwards
Prevalence of asymptomatic (silent) atrial fibrillation in patients treated for hyperthyroidism.
Between 12 and 14 weeks after inclusion
Prevalence of risk factors for stroke in patients with atrial fibrillation
Momentary (day 1, upon inclusion)
Patients with hyperthyroidism admitted for treatment with radioiodine or antithyroid drugs
We will screen all patients residing in the extended region around Stockholm, Sweden who have been referred and admitted to the Radiumhemmet clinic for investigation (and usually treatment) with radioiodine. As of February 2016, we will also include patients referred for treatment with antithyroid drugs at the endocrinology clinics of 1) Sahlgrenska University Hospital, Gothemburg Sweden, 2) Karolinska University Hospital, Stockholm, Sweden, 3) Danderyds Hospital, Stockholm, Sweden
Medicine Clinic, Sahlgrenska University Hospital
Gothemburg, 41345, Sweden
Endocrinology Clinik, Karolinska University Hospital
Stockholm, 17176, Sweden
Medicine Clinic, Danderyds Hospital
Stockholm, 18288, Sweden
Frost L, Vestergaard P, Mosekilde L. Hyperthyroidism and risk of atrial fibrillation or flutter: a population-based study. Arch Intern Med. 2004 Aug 9-23;164(15):1675-8. doi: 10.1001/archinte.164.15.1675.
Osman F, Franklyn JA, Holder RL, Sheppard MC, Gammage MD. Cardiovascular manifestations of hyperthyroidism before and after antithyroid therapy: a matched case-control study. J Am Coll Cardiol. 2007 Jan 2;49(1):71-81. doi: 10.1016/j.jacc.2006.08.042. Epub 2006 Dec 13.
Mårten Rosenqvist, Prof
Karolinska Institutet
110 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2013
First Posted
September 18, 2013
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Metso S, Auvinen A, Salmi J, Huhtala H, Jaatinen P. Increased long-term cardiovascular morbidity among patients treated with radioactive iodine for hyperthyroidism. Clin Endocrinol (Oxf). 2008 Mar;68(3):450-7. doi: 10.1111/j.1365-2265.2007.03064.x. Epub 2007 Oct 17.
Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
Primary Completion
August 2020
Actual (reported)Study Completion
August 2020
Actual (reported)Last Updated
September 4, 2020
Record last verified: 2020-09
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